Regulation on radiation safety in nuclear medicine
(b) the use of unsealed radioactive
CHAPTER I
General provisions
Art. 1 These Norms issued in conformity
with art. 5 of Law No. 111/1996 on the
safety deployment of nuclear activities,
with subsequent modifications and
completions, specify and complete the
requirements on ensuring the radiological
safety for nuclear medicine practice safety
deployment.
Art. 2 The nuclear medicine practice
consists in using the unsealed sources of
ionizing radiations for therapeutic and
diagnostic purposes, either in vitro or in
vivo.
Art. 3 (1) The observance of the
requirements of this norm is the minimum
necessary condition for authorizing the
practice deployment and for demonstrating
the conformity on inspection.
(2) If the applicant/authorization holder
uses other radiological safety analyses
methods than those provided in these
norms, he shall prove that at least the
radiation safety level provided in these
norms is ensured.
Art. 4 (1) These norms recommend the
application of the standards adopted by the
standardization body CENELEC.
(2) The radiation safety authorization for
the equipments bearing the sign EC shall
be issued according to a simplified
procedure.
CHAPTER II
Scope
Art. 5 These norms shall apply to nuclear
medicine practice, which implies:
(a) the use of unsealed radioactive
sources given to the patients in
view of diagnosis and treatment,
health monitoring or research in
the field of diagnosis and therapy
techniques;
sources for studies in vitro in view
of diagnosis, treatment or research;
(c) the use of radioactive sources for
testing, quality control and
calibration of the equipments used
at points a) and b), either sealed
(for example, sources of 57Co used
as phantoms, 137Cs), or unsealed
(99mTc).
CHAPTER III
Structure and authorization of the
practice
Art. 6 The deployment of the nuclear
medicine practice shall be previously
authorized by the National Commission for
Nuclear Activities Control, hereinafter
referred to as CNCAN, in conformity with
the provisions of art. 8 of Law No.
111/1996, republished.
Art. 7 The practice deployment
authorization shall be issued at the request
of the legal person on the condition of
observing the legal provisions in force.
Art. 8 (1) The nuclear medicine practice
deployment shall be authorized by one of
the following components:
a) registration in case of use in vitro
of the unsealed radiation sources on
the condition of
observing/complying with the
provisions of the “Norms on
Radiation Safety. Authorization
procedures”.
b) authorization on realization phases,
in case of diagnostic and therapy
nuclear medicine practice, as it
follows:
i. sitting
ii. construction
iii. use
iv. decommissioning
c) authorization in single phase for the
case mentioned in Art. 5, letter (c).
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 (2) The property transfer on a radiological
equipment, the unsealed radiation sources
or of the locations assigned for the practice
deployment, shall require the prior
granting of an authorization issued by
CNCAN.
(3) The leasing of the radiological
equipments, of the unsealed radiation
sources or of the locations assigened for
the practice deployment shall require the
previous granting of an authorization
issued by CNCAN.
(4) On the leasing period of the
radiological equipments, of the unsealed
radiation sources and of the nuclear
medicine lab their owner shall hold the
valid possession and leasing
authorizations.
(5) The unsealed radioactive sources used
in the nuclear medicine are consumables
and shall be supplied by the producers and
suppliers authorized by CNCAN, in
conformity with Law No. 111/1996,
republished, with subsequent modifications
and completions.
Commissioning – granting of the use
authorization
Art. 9. Prior to the ionizing radiations
nuclear medicine practice deployment, the
applicant shall obtain the authorization for
nuclear each activity/activities deployment
that is/are included in the practice
deployment.
Art. 10. (1) The technical authorization
documentation necessary for obtaining the
radiological safety authorization for
nuclear medicine practice deployment shall
include all the information necessary for
proving the observance of the specific
regulation’s provisions applicable to the
practice and shall allow the assessment of
the radiological safety realization degree.
(2) An application form model and the
technical documentation necessary for
obtaining the radiological safety
authorization for nuclear medicine practice
deployment are presented in Appendix No.
2.
Art. 11. In addition to the general
requirements provided in Art. 62 to the
Norms on Radiation Safety. Authorization
procedures, the submitted technical
documentation shall prove that at least the
following conditions have been complied
with:
(a) the endowments have been realized
in conformity with the
documentation based on which the
sitting construction authorization
have been granted and with the
conditions imposed by it;
(b) the efficiency of the protection
shields is proved by the
measurements carried out under the
most unfavourable/unpropitious
conditions: the highest activity of
the radioactive source, the highest
energy of the radiation beam and
the most unfavourable/unpropitious
irradiation direction;
(c) the warning, signaling, centralized
dosimetry and the radiological
safety systems have been
installed/mounted and function in
conformity with the sitting
construction documentation;
(d) the acceptance tests for the
equipments to be used have been
carried out;
(e) the radiation protection system is
operational.
Decommissioning
Art. 12 (1) The decommissioning of the
nuclear medicine labs used for in vivo
radio-diagnosis and for the unsealed
radioactive sources therapy needs the prior
granting of the decommissioning
authorization by CNCAN.
(2) Upon ceasing the activity, the
authorization holder shall prove, as
applicable, the followings:
(a) the decommissioning was carried
out by a specialized unit,
authorized by CNCAN, in
accordance with the law, to handle
unsealed sources;
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 (b) the radioactive sources transfer or
disposal as radioactive waste;
(c) the absence of the areas
contamination and waste disposal
of all materials found as
contaminated;
(d) the absence of contamination of the
equipments and materials, of the
sewerage, ventilation systems and,
generally, of all disposed materials;
(e) removal of the warning signs.
(3) The ceasing of the activity shall come
into force under the condition of observing
the provisions of art. 101 of the Norms on
radiation safety – Authorization
procedures.
(4) The decommissioning of the nuclear
medicine labs used for in vitro radio-
diagnosis shall not need the issuing of a
CNCAN decommissioning authorization if
the decommissioning is carried out by a
specialized unit authorized by CNCAN to
handle unsealed radioactive sources, being
included in the authorization process upon
registration.
Control
Art. 13. (1) The CNCAN control has as
main objective the checking up of the
nuclear medicine practice safety
deployment method, in all the phases of
the authorization process, by controlling
the way of fulfilling the radiological safety
requirements, imposed by:
(a) Law No. 111/1996, republished,
with the subsequent modifications
and completions;
(b) these Norms;
(c) the Fundamental Norms on
Radiation Safety and by other
norms issued by CNCAN,
applicable to the nuclear medicine
practice, specified in Appendix
No.1;
(d) limits and conditions specified in
the authorization issued by
CNCAN.
(2) The authorization holder shall allow the
carrying out of the control by the
CNCAN’s representatives, in conformity
with Law No. 111/1996, republished, with
the subsequent modifications and
completions, placing at their disposal all
the information, technical data and the
necessary records, as well as by:
(a) the direct monitoring of the CNCAN’s
representatives of the activities deployed in
the nuclear medicine laboratories;
(b) CNCAN’s representatives discussions
with the personnel involved in the
activities deployed in the nuclear medicine
laboratories;
(c) the carrying out by the CNCAN’s
representatives of the independent
measurements of the contamination and
ionizing radiation levels.
(3) The radiation safety assessment
questionnaire that may be used by the
authorization holder to identify and
prepare the major aspects monitored within
the CNCAN’s control is presented in
Appendix No. 3.
CHAPTER IV
Justification, optimization and
limitation of the doses
for the nuclear medicine practice
deployment
Justification of the practice
Art. 14. (1) According to the present
knowledge the nuclear medicine practice is
considered to be justified.
(2) Re-assessment of some particular
forms of the practice is part of the
optimization action, may be initiated and
coordinated by CNCAN that may limit the
practice extension or decide the forbiddace
of some particular unjustified forms.
(3) The introduction, as regards the
practice, of some new nuclear medicine
techniques shall be motivated and
authorized by the Ministry of Health
according to Art. 38 of Law No. 111/1996
on the safety deployment of the nuclear
activities, republished, with the subsequent
modifications and completions.
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 Optimization of the practice
Art. 15 (1) The applicant or the
authorization holder, respectively, shall
prove that all actions for ensuring the
radiation protection optimization are
undertaken, in the sense of ensuring the
necessary measures so that all exposures,
including the potential exposures arising
from the nuclear medicine practice shall be
kept at the lowest possible level, taking
into consideration the economic and social
factors – ALARA principle.
(2) The authorization applicant shall
submit to CNCAN a documentation
proving that all requirements on radiation
protection and radiological safety referring
to the following aspects are being met:
(a) design and construction of the
locations, choosing the equipment
and the radiation sources;
(b) the operational radiation protection
system;
(c) use, under safety conditions, of the
radioactive sources and existence
of a record system thereof;
(d) personnel’s training and
authorization.
Limitation of doses
Art. 16 (1) The maximum admitted limit of
the effective dose for the occupational
exposed workers deploying nuclear
medicine practice with ionizing radiations
is provided in art. 22 of the Fundamental
Norms on radiological safety.
(2) In the nuclear medicine practice control
and authorization process, CNCAN shall
check up:
(a) the observance of the medical exposure
reference levels;
(b) the observance of the dose constraints
for the persons that consciously and
voluntarily help, outside the own activity,
at the support and sustaining of the patients
in course of diagnosis and treatment;
(c) the observance of the dose constraints
for the persons participating at the
biomedical and medical research
programs;
(d) derived emission limits of the
radioactive effluents.
Special authorized exposures
Art. 17 (1) Under extraordinary
circumstances, CNCAN may authorize the
individual occupational exposure of some
workers which may exceed the effective
dose limit provided in art. 22 paragraph (1)
of the Fundamental Norms on Radiation
Safety, on the condition that these
exposures are limited in time, restricted to
some working area and included under the
maximum value approved by CNCAN for
the equivalent dose limits provided in
paragraph (2) of the same article.
(2) In these cases the authorization holder
shall act in conformity with the provisions
of art. 31 and 32 of the Fundamental
Norms on Radiological Safety.
CHAPTER V
OPERATIONAL RADIATION
PROTECTION SYSTEM
Art. 18 (1) The authorization holder shall
set up and keep an operational radiation
protection system.
(2) The operational radiation protection
system represents the totality of actions,
procedures necessary for ensuring the
nuclear medicine practice deployment with
ionizing radiations under radiological
safety conditions.
(3) The objectives of the operational
radiation protection system are:
(a) defining the licensee’s
responsibilities on radiation
protection by adopting the
organizational structures and the
necessary procedures;
(b) reducing at minimum the risk of
exposure to radiations of the
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 occupational exposed workers, of
the other persons of population
and of those subject to diagnosis
or treatment with unsealed
radiation sources;
(c) observance of the ALARA
principle;
(d) setting the requirements on quality
assurance in operation, including
the checking up of the radioactive
sources, radiological equipments
and dosimetric control
equipment/devices;
(e) setting the safety and physical
protection measures of the
radioactive sources;
(f) observance of the regulation
requirements;
(4) The operational radiation protection
system implies at least the following
measures:
(a) observance of the general radiation
protection principles provided in
art. 37 of the Fundamental Norms
on Radiological Safety;
(b) elaboration and implementation of
the procedures regulating the
practice deployment according to
the requirements of these Norms;
(c) the use, as regards the practice,
only of the persons possessing
exercising permit valid for the
respective activity;
(d) assigning in written of the
responsibilities on the radiological
safety.
Art. 19 (1) The operational radiation
protection system is based on a general
practice deployment procedure that shall
set out:
(a) organization and practice deployment
forms;
(b) controlled and monitored zones;
(c) obligations and responsibilities of all
the factors involved;
(d) administrative relations between the
involved factors;
(e) the system documents: record,
archive, distribution, withdrawal;
(f) necessary evidence;
(g) sanctions.
(2) The operational radiation protection
system shall be completed, at least with the
following operational procedures and
instructions:
(a) individual dosimetric control
procedure;
(b) workplace radiological monitoring
procedure;
(c) clinical dosimetric procedure;
(d) diagnosis procedures;
(e) procedures applicable in case of
therapy with unsealed ionizing radiations
sources;
(f) patients release procedure, as
applicable.
(g) procedure on the radiological
equipments and radiation sources record,
movement and disposal;
(h) quality control procedures for every
equipment used in the nuclear medicine
laboratory;
(i) procedure on setting out the controlled
and supervised areas and on the access
control within the controlled area;
(j) radioactive waste collecting and
disposal procedure;
(k) equipments and installations usage
procedures;
(l) procedure on investigation and
reporting of abnormal and overexposure;
(m) intervention procedure in case of
emergency.
(4) The procedures shall ensure the
transposition of the nuclear regulation
requirements to the nuclear medicine
practice deployment concrete conditions.
(5) The procedures of the operational
radiation protection system that refer to the
improvement of the patients caring results
and quality, shall be regularly checked up
by clinical audits that shall be carried out
in conformity with the regulation specific
to the Ministry of Health.
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 Responsibilities
Art. 20 The authorization holder shall have
the following duties:
(a) to ensure that the nuclear medicine
practice is deployed in conformity
with the provisions of Law
111/1996, republished;
(b) to notify CNCAN on any intention
of authorized practice modification;
(c) to ensure the proper spaces and
endowments for nuclear medicine
practice deployment;
(d) to ensure the proper endowment
with equipments, dosimetric
control devices, accessories and
consumptible articles necessary to
conduct the practice;
(e) to ensure the conditions necessary
so that all used equipments are in
good operational condition and
properly maintained;
(f) to ensure authorized dosimetric
surveillance means and dosimetric
services approved by CNCAN to
the occupational exposed workers
of A category;
(g) to ensure the means necessary for
the radiological and working
environment monitoring and to
keep a record of the results;
(h) to ensure the conditions necessary
so that the dosimetric control
equipment is in good operational
condition and metrologically
checked up;
(i) to prepare and to implement an
operational radiation protection
system which shall include the
procedures and standards
applicable for the use, under safety
conditions, of the radiological
equipments and of the radiation
sources by the operators;
(j) to assign at least one person
responsible for radiological safety
for each controlled area in order to
ensure the implementation of the
operational radiation protection
system;
(k) to issue level I-exercising permits
for the personnel that do not
possess exercising permit issued by
CNCAN;
(l) to consult and to contract radiation
protection qualified experts
whenever necessary;
(m)to consult and contract medical
physics experts;
(n) to request the carrying out of
radiation safety assessments for
identifying the normal exposure
sources and the predictable
potential exposure sources, for
estimating the probability and size
of the doses resulted in these cases
and for assessing the methods and
means necessary to ensure the
radiation protection and the
radiological safety;
(o) to ensure that the personnel
conducting nuclear medicine
practice has the necessary training
in conformity with the provisions
of art. 28 and 29 and to ensure the
conditions necessary for its
participation at improvement
courses in conformity with the
provisions of art. 30;
(p) to ensure the proper training of the
personnel involved in the practice
deployment as regards the radiation
protection and radiological safety,
the working procedures, the
regulation in the field and the
intervention plan in case of incident
in conformity with the provisions
of art. 28, 29 and 30 and to keep
the records provided in art. 32;
(q) to organize the record of the
individual monitoring results for
each occupational exposed worker
of A category as a consequence of
nuclear medicine practice
deployment, as well as for all the
persons subject to accidental or
emergency exposure in conformity
with the provisions of art. 64 of the
Fundamental Norms on
Radiological Safety;
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(r) to prepare the intervention plan in
case of radiological incident;
(s) to ensure the endowment necessary
for the intervention in case of
incidents involving used ionizing
radiation sources;
(t) to ensure, as applicable, the
conditions for radioactive waste
disposals, return to the
supplier/manufacturer and/or
release of the radioactive sources
out of use or of the contaminated
objects arisen from the nuclear
medicine practice deployment;
(u) to ensure according to the
regulation of the Ministry of Health
the medical surveillance of the
occupational exposed workers and
a special medical surveillance of
the occupational exposed workers
to doses exceeding the dose limits
provided in art. 22 of the
Fundamental Norms on
Radiological Safety;
(v) to ensure that the occupational
exposed workers have the medical
approval necessary for occupying
the respective job position;
(w) to ensure the information of the
occupational exposed workers and
of the persons in course of training
in conformity with the provisions
of art. 49 of the Fundamental
Norms on Radiological Safety;
(x) to allow the designated CNCAN
representatives to exercise the
control mandate in conformity with
the provisions applicable to Law
No.111/1996, with subsequent
modifications and amendments and
to ensure the participation at
control of the person responsible
for radiological safety or, as
applicable, of the qualified expert;
(y) to fulfill any other responsibilities
necessary for the safety deployment
of the nuclear medicine practice
with ionizing radiations;
(2) In case of non-observance of the
authorization conditions the authorization
holder shall:
(a) investigate the causes,
circumstances and consequences of
the event;
(b) take the necessary measures for
eliminating the causes and limiting
the consequences, shall notify
CNCAN and the other bodies with
responsibilities, whenever the case;
(c) cease the activity if it presents
radiological risks or risks of other
nature, unacceptable for the own
personnel or for the patient;
(d) monitor the application of the
measures assigned by CNCAN;
Art. 21 (1) The responsibilities on radiation
protection and radiological safety shall be
clearly defined, in written, and the
qualification of each person invested with
responsibilities shall be proved in
conformity with the provisions of art. 2 of
this article.
(2) The person responsible for radiation
protection (RPO) shall:
(a) possess a level 2 exercising permit
for the practice field and specialty;
(b) be invested with enough authority
to be able to impose the observance
of the authorization conditions and
to stop the work/ activity in case of
non-deployment under safety
conditions;
(3) The attributions and responsibilities of
the person responsible for radiation
protection (RPO) are:
(a) to supervise that the practice is
carried out under observance
conditions of procedures and terms
stipulated in the authorization and
in the inspection reports;
(b) to ensure that only the well-trained
workers conduct activities with
ionizing radiation sources;
(c) to apply the emergency procedures;
(d) to keep the record of the
metrological checking up of the
dosimetric control equipment and
to check up its use method;
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(e) to organize the examination of the
entire occupational exposed
workers that do not possess an
exercising permit issued by
CNACN in view of issuing by the
authority holder of the level 1-
exercising permit;
(f) to draw up and to periodically
review the laboratory’s procedures
in view of conformity with the
regulation requirements;
(g) to prepare and to review the
working procedures so that the
radiation exposure is kept at a level
as low as possible (ALARA);
(h) to ensure the equipments use
specifications are known by the
users;
(i) to ensure the drawing up and
application of the intervention
plans in case of radiological
emergency;
(j) to ensure the equipments and the
radiation sources are periodically
checked up and authorized in
conformity with the regulation in
force;
(k) to identify and to delimitate the
supervised and controlled areas and
to set the access control and
security measures for these areas;
(l) to ensure the proper individual
dosimetric monitoring (external
and internal, as applicable) of the
occupational exposed workers and
to keep the records;
(m)to ensure the radiological
monitoring of the working
environment and to keep the
records;
(n) to investigate the
accidents/incidents, over-exposures
and to propose corrective and
preventing measures;
(o) to set out the additional radiation
protection measures necessary for
the pregnant women;
(p) to keep daily record of the radiation
sources and of the radioactive
waste , including the radioactive
effluents evacuated in the sewerage
syatem ;
(q) to conduct periodical audits on the
radiological safety and to keep the
records of the results and of the
proposed corrective and preventing
measures;
(r) to identify the situations in which a
radiation protection expert shall be
consulted;
(s) to verify the solving procedure of
the problems mentioned by the
expert qualified in radiation
protection according to his
responsibilities laid down in art. 20;
(t) to periodically inform the
authorization holder on the
conducted activity and on the
necessary corrective and preventing
measures;
(u) to immediately inform the
authorization holder on any event,
accident/incident arisen from the
nuclear medicine practice.
(4) If several persons responsible for
radiological safety are appointed, their
attributions shall be clearly defined in
written so as not to overlap.
(5) The radiological safety responsible
shall be responsible for the content,
management and archiving of the technical
documentations regarding the controlled
area for which he was appointed.
Art. 22 The responsibilities of the nuclear
medicine physician are:
(a) to ensure the radiation protection of the
patient;
(b) to prescribe and to motivate in written
the medical exposures by taking into
consideration the relevant information
given by the previous examinations;
(c) to ensure the patients exposure is
minimum in order to obtain the desired
result by taking into account the
reference levels for the medical
exposures as regards the diagnosis;
(d) to consult and to clinically assess the
patient;
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(e) to set out optimized protocols for the
therapy and diagnosis procedures
together with the appointed medical
physics expert;
(f) to medically assess any
incident/accident;
(g) to set out criteria for: children and
pregnant women examination, medical-
legal procedures, medical examinations
of the occupational exposed workers
and biomedical researches.
Art. 23 The responsibilities of the medical
physics expert are:
(a) to participate at the continuous
assessment of the resources used in
the nuclear medicine practice and
of the procedures;
(b) to participate at the carrying out of
the equipments acceptance tests;
(c) to prepare the equipments
performance specifications, taking
into consideration the radiation
protection requirements;
(d) to monitor the equipments
maintenance method;
(e) to design, implement and supervise
the quality control procedures;
(f) to do the necessary calculations to
estimate the doses absorbed in the
relevant organs and the effective
dose for the activity administrated
to the patient, in conformity with
the clinical protocol and/or the
international recommendations on
the patients internal dosimetry;
(g) to participate at the carrying out of
the quality control regular tests at
the dose calibrators, at the
radiations monitors, at gamma
cameras and at other relevant
equipments, in conformity with the
established procedures;
(h) to calculate the activity to be
administered to the children for a
specific procedure, using the proper
scaling, in conformity with the
Norms on radiation protection of
the persons in case of medical
exposures to ionizing radiations;
(i) to verify the way the activity is
measured prior to administration;
(j) to participate at the investigation
and assessment of the incidents and
accidents;
(k) to participate at the personnel
training program.
Art. 24 The responsibilities of the nuclear
medicine assistant are:
(a) to observe the radioprotection
rules, the working instructions and
procedures;
(b) to ensure the patients identification
is correct and the information given
by the patients are correctly
registered;
(c) to give the patients information on
the respective procedure;
(d) to give information to the persons
accompanying the patients and to
the personnel assisting the patients
that have been following a nuclear
medicine procedure (diagnosis or
therapy);
(e) to check up if the women patients
are pregnant;
(f) to ensure the patients breast feeding
were given information on the
cessation of the breast feeding;
(g) to ensure that radiopharmaceuticals
absorption blocking methods in the
organs not subject to study or that
excretion accelerating methods are
used according to the specifications
of the nuclear medicine physician;
(h) to correctly do the acquisition and
the processing of the image
(i) to inform the person responsible for
radiological protection on the
incidents/accidents;
(j) to immediately inform the person
responsible for radiation protection
(RPO) on the flaws/malfunctions
discovered at the equipments and
not to use the damaged or
incorrectly maintained equipments;
(k) to inform the person responsible for
radiation protection (RPO) and the
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 nuclear medicine physician on any
incorrect administration;
(l) to correctly use the dosimetric
surveillance means with which he
is equipped;
(m)to correctly use the individual and
collective radiation protection
means;
(n) to report the over-exposures in
conformity with art. 83 of the
Fundamental Norms on
Radiological Safety;
(o) to participate according to his
attributions to the actions laid down
in the intervention procedure in
cease of emergency;
(p) to participate at the training of the
persons regarding the nuclear
medicine practice;
(q) the assistants may have other
responsibilities as well, that belong
to the radiation chemist, as
applicable:
- preparing of the
radiopharmaceuticals in
conformity with the
manufacturer’s specifications and
with the working procedures;
- to carry out the quality control
procedures at the preparing of the
radiopharmaceuticals.
Art. 25 The persons in course of training
shall carry out their activity only with
assistance given by the person responsible
for radiation protection (RPO) or the
nuclear medicine physician.
Art. 26 The attributions and
responsibilities of the persons in course of
training are:
a) to work under the supervision of the
of the person responsible for
radiation protection (RPO) or the
nuclear medicine physician;
b) to comply with the radiation
protection rules;
c) to correctly use the individual
dosimetric means;
d) not to use out-of-order or improperly
maintained equipments;
e) to immediately inform the person
responsible for radiation protection
(RPO) or the nuclear medicine
physician on any found malfunction
or nonconformity.
Art. 27 (1) The attributions and
responsibilities of the radiation protection
qualified experts are:
(a) to check up the application of the
ALARA principle in the practice
deployment;
(b) to check up the classification of
areas proposed by the authorization
holder in view of confirming the
compliance with the requirements
on the controlled and supervised
areas;
(c) to motivate the application for
authorization of special exposures
and of individual occupational
exposure of certain workers
exceeding the effective dose limit
of 20 mSv/year, under exceptional
situations, but that exclude the
radiological emergencies;
(d) to identify the situations where
there is the possibility that the A-
category occupational exposed
workers suffer a significant internal
contamination and to propose the
monitoring of these persons
internal contamination by approved
dosimetric bodies;
(e) setting the radioactive waste
disposal procedures arisen from the
nuclear medicine practice;
(f) to confirm the dose assessment
results arisen from the emergency
or accidental exposures.
(2) The radiation protection qualifued
expert shall offer assistance for:
(a) the previous critical examination of
the construction and sitting plans
for practice deployment, from the
point of view of radiological
safety;
(b) identification, in view of use, only
of the equipments and radiation
sources for which a radiological
safety authorization exists;
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 (c) the periodically checking up of the
equipments, of the radiation
sources and of the protection
techniques, devices and
equipments efficiency, the labeling,
periodical checking up of the
measure equipments, as well as the
assessment of their proper use;
(d) setting the operational radiation
protection system in the authorized
practice;
(e) the investigation and assessment
processes in case of abnormal
exposures or over-exposures, in
order to determine the
circumstances the over-exposure
occurred, to assess the received
doses and to prevent the repetition
of such over-exposures.
Personnel training
Art. 28 The personnel carrying out nuclear
medicine practice shall have:
(a) general training appropriate for
their job;
(b) training in the field through
corresponding nuclear medicine
courses, in conformity with the
requirements of Ministry of Health;
(c) training in the radiation protection
field through corresponding
training courses approved by
CNCAN;
(d) knowledge on the radiation
protection system;
(e) practice training regarding the
ionizing radiation nuclear medicine
practice deployment and the
radiological emergency
intervention procedures;
(f) corresponding exercising permits to
conduct the practice.
Art. 29 (1) The syllabus of the radiation
protection training courses organized by
the authorization holder shall observe the
theme from the Norms on issuing the
nuclear activities exercising permits and on
assigning the radiation protection qualified
experts and shall be approved by CNCAN.
(2) The minimum time period of a 1-level
training program in the radiation protection
field shall be of 30 hours.
(3) The minimum time period of a 2-level
training program in the radiation protection
field shall be of 30 hours for the long-term
academic graduates and 60 hours for the
other cases.
(4) The minimum time period of a
retraining program in the radiation
protection field shall be of 24 hours.
Art. 30 (1) The authorization holder shall
ensure the corresponding training in the
field of radiological safety of the
occupational exposed workers and its
professional re-training at least once at
every 5 years by a training system
approved by CNCAN or in training centers
authorized by CNCAN.
(2) The authorization holder shall train the
persons in course of training before they
use the ionizing radiation sources
equipments.
Art. 31 The authorization holder shall
ensure that the person responsible for
radiological safety and the occupational
exposed workers know the followings:
(a) the authorization conditions and
limits;
(b) the operational radiation protection
system drawn up at the
organization level;
(c) the use and maintenance
instructions of the used equipments
and facilities;
(d) the risks associated to the practice
deployment;
(e) the working procedures;
(f) the radiological emergency
intervention procedures.
Art. 32 (1) The authorization holder shall
set up and keep records on the training of
the personnel conducting nuclear medicine
practice. These records shall include at
least the following information:
(a) the name and surname of the
person following the training
course;
11
 (b) the identification data of the
institution organizing the course;
(c) the duration of the course;
(d) the course syllabus;
(e) the copy of the training program
graduation certificate.
(2) A training plan of the personnel
conducting nuclear medicine practice shall
be annually drawn up.
Individual monitoring of the radiation
occupational exposed workers
Art. 33 (1) The authorization holder shall
ensure the systematic individual
monitoring of all the A-category
occupational exposed workers.
(2) The internal contamination
monitoring, if necessary, shall be carried
out either by external monitoring of the
thyroid or by whole body counter
measurements.
(3) The monitoring of the hands
extremities, if applicable, shall be carried
out by proper dosimetric systems.
(4) The monitoring shall be carried out by
an approved individual dosimeter body.
Art. 34 (1) The authorization holder shall
set up and keep a procedure on dosimetric
monitoring activity deployment of the
occupational exposed workers and of dose
attribution. This procedure shall include at
least the following information:
(a) description of the adopted
dosimetric systems (film, thermo
luminescent dosimetry, digital
electronic dosimeters etc.);
(b) person responsible for receiving-
delivery of the dosimeters between
the unit and the approved
individual dosimetric bodies;
(c) person responsible for receiving-
delivery of the dosimeters between
the unit and the occupational
exposed workers;
(d) person responsible for the keeping
the dose records and the recording
methods;
(e) place of storage of the unused
dosimeters, kept away from the
possibility of accidental exposure
to radiations;
(f) wearing and use instructions;
(g) instructions for cases of theft,
incorrect exposures, loss or other
events leading to errors regarding
dose registration;
(h) dosimetry for accidental exposure
or intervention cases;
(i) dose attribution methods for the
cases specified at letters (g) and
(h);
(j) record/registration methods;
(k) sanctions/penalties
(2) The authorization holder shall annually
analyze the doses received by the
occupational exposed workers and the
radiation protection program application
measures.
Art. 35 The occupational exposed workers
shall follow the dosimeters wearing and
using rules and shall protect them against
theft, loss or damage.
Art. 36 The occupational exposed workers
shall return the dosimeters at the end of the
monitoring period and shall inform the
person responsible for radiation protection
(RPO) on any theft, loss, damage or
incorrect exposure to radiation of the
dosimeters.
Art. 37 In case of accidental exposures the
authorization holder shall ensure for all the
persons involved the immediate
assessment of the individual doses arisen
from external exposure.
Art. 38 In case of emergency exposures the
authorization holder shall ensure the
individual dosimetric monitoring and/or
the assessment of the received doses, as
applicable.
Art. 39 The authorization holder shall
consult a radiation protection qualified
expert with respect to the confirmation of
the doses assessment results arisen from
the accidental or emergency exposures.
Art. 40 (1) The authorization holder shall
request at the employment of an
occupational exposed worker his/her
12
declaration on the doses previously
received as occupational exposed person.
(2) The authorization holder shall request
to the last employer of the person in
question the official sending of the extras
of the received dose evidence.
Art. 41 The authorization holder shall
inform the person on his/her individual
monitoring results and shall ensure the
access to the measurements results used for
dose assessments and to the working
environment radiological results used for
the assessment of doses received by the
person in question.
Art. 42 The authorization holder shall
place at the competent physician’s disposal
the results of the individual dosimetric
monitoring results in view of reading the
implications of radiation exposures on the
health state of the exposed persons.
Art. 43 The authorization holder that
ensured the individual monitoring of an A-
category occupational exposed worker
involved in nuclear medicine practice
deployment shall ensure, upon request, the
sending of the respective individual
monitoring results to the the authorization
holder or to the foreign bodies contracting
the person in question as an occupational
exposed worker.
Investigation levels
Art. 44 Values exceeding 0.5 mSv
registered by the personal dosimeters
during a month or values exceeding 12
mSv for hand extremities/fingers are
examples of investigation levels.
Art. 45 (1) The authorization holders,
subsequent to the discussion with the
person responsible for radiation protection
(RPO) and the radiation protection
qualified expert, shall include in the
procedures the investigation levels values,
including for other values than those
specified in Art. 44, if applicable, and the
measures to be taken in case of exceeding
these values.
(2) The exceeding of these values implies
the checking up of the procedures, working
instructions and operational radiation
protection system, in collaboration with the
qualified expert in radiation protection that
supervises the activity deployment and the
necessary corrective measures application.
(3)The person responsible for radiation
protection (RPO) shall initiate his own
investigations when:
(a) the individual effective dose
exceeded the corresponding
investigation level;
(b) the operational parameters relevant
for the radiation protection are
outside the normal interval;
(c) any equipment damage, any serious
accidents or any errors/faults may
lead to or may cause an exceeding
of the dose limits;
(d) any other event or circumstance
may lead to or may cause an
exceeding of the dose limits or of
the equipment operational
restrictions.
(4) The investigation shall start as soon as
possible after the incident occurred, and a
written report on the event cause,
determination and checking up of the
received doses, corrective actions,
specifications and recommendations to
avoid a possible recurrence shall be drawn
up within 10 days.
(5) The exceeding of the investigation
levels and of the preventive and corrective
measures shall be reported to CNCAN
within 10 days from the date of
observance.
Investigation and notification on the
over-exposures and the abnormal
exposures
Art. 46 (1) The authorization holder shall
set up and keep a procedure on the
investigation and notification regarding the
over-exposures and the abnormal
exposures. The procedure shall provide:
13
 (a) the immediate notification of the
affected person;
(b) the immediate notification of
CNCAN, of the competent
physician and of the external
worker employer (if the person in
question is an external worker) on
the presupposed over-exposure and
on the preliminary assessed doses;
(c) the drawing up of a report on the
event within 10 days from the
beginning of the investigation;
(d) means of contacting a radiation
protection qualified expert for
consultancy;
(2) The report shall contain at least the
following information:
(a) the results of the investigation
based on which the preliminary
value of the received doses was
established;
(b) the circumstances in which the
over-exposure occurred;
(c) the assessment of the received dose
based on all the available data,
including the individual dosimetric
measurements results;
(d) the measures taken in order to
prevent the reoccurrence of such
over-exposures.
Art. 47 The occupational exposed workers
that have been over-exposed may continue
to work in the controlled areas if there are
no medical counter-indications.
The radiological monitoring of the
working environment
Art. 48 (1) The radiological monitoring of
the working environment shall include the
measurement of the dose rates due to
external exposure and to contamination.
(2) The monitoring of the dose rates due to
external exposure is compulsory for all the
controlled zones with a 3-months
frequency.
(3) The contamination monitoring is
compulsory for:
(a) all the working areas, including their
interior (as applicable), the tools,
equipments, floor and other object
removed from the respective area;
(b) the personal clothes and protection
equipment, including the shoes, especially
when the person works in a controlled
area. For this purpose, a monitoring device
shall be placed at the exit from the area
(c) the clothes and linen of the patients
suspected of contamination;
(d) the hands of the persons using unsealed
sources shall be monitored by devices
placed near the washing place. The
monitoring shall be extended to other parts
of the body as well, if there is the suspicion
of contamination.
(4) The area and working environment
radiological monitoring shall be carried out
by the own personnel, properly trained,
with the own equipments, or by an external
qualified body.
(5) The measurements results shall be
registered during the practice deployment
and shall be used, if necessary, for the
assessment of the individual doses. The
minimum time period for keeping the
records laid down/provided in paragraph
art. 50 is of 10 years.
Art. 49 The authorization holder, by the
consultation with a radiation protection
qualified expert, shall set up and keep a
procedure on the radiological monitoring
of the working environment. The
procedure shall contain at least the
following information:
(a) the measurement methods and
equipment, including the checking
up methods prior to using the
dosimetric control device;
(b) nuclear medicine laboratory plan
and the measuring points;
(c) the measurements frequency;
(d) responsibilities;
(e) recording and reading of the
results;
(f) corrective measures that shall be
taken in case of exceeding the
investigation levels set out in the
local rules.
14
Art. 50 The record shall include at least the
following information:
(a) the plan of the laboratory,
specifying the areas adjacent to the
radiation sources storage or
investigation/treatment rooms and
the point where the measurements
shall be carried out;
(b) the measurements date;
(c) the name of the person carrying out
the measurements;
(d) the used dosimetric control
equipment type and its
identification data (series, date of
the last metrological checking up);
(e) the obtained values for the dose
rate and/or contamination.
Art. 51 The authorization holder shall
ensure the endowment with at least one
survey meter and one contamination
monitor or with one single dosimetric
control device if the last may function as a
survey meter or as contamination monitor.
Art. 52 (1) The used dosimetric control
equipment shall have a radiological safety
authorization and shall be in conformity
with the radiations type emitted by the
source used in the practice deployment.
(2) The survey meter shall be calibrated in
dose rate units in order to indicate, at least,
values between 1 μSv/h and 10 mSv/h with
a precision of minimum +/- 30% and shall
be provided with a sonorous signaling that
may be reduced when working near
patients.
(3) The contamination monitor shall detect
beta radiation, upon the case.
Art. 53 (1) The dosimetric control
equipment shall be checked up at the
beginning of each working shift. This
inspection shall include:
(a) the checking up of the supply
batteries status;
(b) measuring of the natural radiations
background;
(c) response in case of approaching to
an exposure container or in case of
using a test source.
(2) The checking up laid down in
paragraph (1) shall fall under the
responsibility of the person responsible for
radiation protection (RPO) or of another
person appointed , in written, by the latter.
Art. 54 The dosimetric control equipment
shall be metrologically checked up within
the time period recommended by the
manufacturer or that written in the type
approval authorization by units authorized
by CNCAN as notified bodies for
metrological checking ups.
Requirements on radioactive sources
Art. 55 (1) The unsealed radioactive
sources administrated in the human
medicine for diagnosis, therapeutic and
scientific research purposes are
radiopharmaceutical products.
(2) The RIA kitts for “in vitro” diagnosis
are not considered radiopharmaceutical
products.
Art. 56 The introduction of the
radiopharmaceuticals that may be used in
the human medicine and the quality
requirements they have to fulfill shall be
set out by the Ministry of Health that, in
conformity with the provisions of art. 38
paragraph (1) letter b) of Law No.
111/1996 republished with subsequent
modifications and completions, shall
authorize their use for diagnosis or
therapeutic purposes.
Art. 57. For the radiopharmaceuticals and
RIA kitts containing radioactive material,
the type approval authorization needs to be
granted prior to their use.
Art. 58 The radiopharmaceuticals and RIA
kitts shall comply with the requirements of
the applicable radiation protection and
pharmaceutical standards on:
15
 (a) purity of the radionuclides;
(b) specific activity;
(c) radiochemical purity;
(d) chemical purity;
(e) pharmaceutical properties: toxicity,
sterility, pyrogenicity etc.
Art. 59 The authorization holder shall set
out a radiopharmaceuticals and RIA kitts
quality control procedure regarding their
preparedness for administration. The
procedure shall include:
(a) written instructions at the receiving
the radiopharmaceuticals or
generators (checking up of the
correlation between the documents
on the package and the written
ones, visual inspection,
measurements of the activity,
proper storage etc.);
(b) written specifications on
radiopharmaceuticals preparedness
and administration according to the
manufacturer’s indications;
(c) quality control tests regarding the
radionuclides generators including:
elution activity monitoring (daily)
as an indicator of generator’s
operation, measurement of the
parent radionuclide passing in
eluent, chromatographic tests for
the marking percentage with
radioactive trasor;
(d) monitoring of the preparing
conditions (hygiene,
contamination, aseptics etc.)
(e) vials labeling and marking method
(radionuclide, compound, activity
at the date in question, solution
volume etc.);
(f) used equipments (for example,
radiochromatography equipment,
sterility control equipments,
activity meters etc.);
(g) records on the activity injected to
the patients (injection date,
patient’s name,
radiopharmaceutical, injected
activity etc.)
Art. 60 The radiopharmaceuticals and RIA
kitts shall be properly labeled. The label
shall include the following information:
(a) radionuclide and the chemical
denomination of the preparation;
(b) total activity/measuring date;
(c) expiry date;
(d) number of the manufacture batch;
(e) solution volume for the liquid state
products;
(f) manufacturer’s name and address.
Requirements on equipments
Art. 61 All the equipments used in the
nuclear medicine shall possess the type
approval authorization.
Art. 62 (1) The authorization holder shall
set up and keep an equipments
maintenance and a checking up program
that shall take into consideration the
manufacturer and the supplier’s
recommendations, as well as the
acceptability criteria provided in Norms on
radiation protection of the persons in case
of medical exposures.
(2) The maintenance works and checking
up program shall include:
(a) the acceptance/reference tests
carried out by units authorized by
CNCAN in conformity with Law
No. 111/1996 republished with
subsequent modifications and
completions, before operation in
order to ensure their safety
operation and according to the
manufacturer’s specifications;
(b) the periodical tests (long term
stability tests) carried out by units
authorized by CNCAN in
conformity with Law No. 111/1996
republished with subsequent
modifications and completions, at
intervals of one year for the
equipments less than 10 years old
and at every 6 months for the
others;
16
 (c) routine tests (daily, weekly,
monthly) carried out by the persons
designated in written by the RPO, at the
beginning of the working program. Any
fault regarding the operation of the facility
equipment shall be notified to the person
responsible for radiation protection (RPO).
(3) The results of the periodical and routine
tests shall prove the conformity with the
results of the acceptance/reference
checking ups.
(4) The results of the acceptance/reference
tests, of the periodical and routine tests,
including the information on the
discovered faults and on the repairs carried
out for every equipment type shall be
recorded in a special register.
(5) The acceptance tests shall be carried
out after every repair or replacement of a
component that may affect the parameters
specified by the manufacturer.
(6) The quality control procedures shall
include, for every type of equipment used
in the nuclear medicine laboratory, at least
the following information: the type of the
checking up necessary for every
equipment, specific testing procedures,
measurements frequency, data processing,
reading of the results, acceptability limits,
measuring equipments, test radioactive
sources and other materials necessary for
carrying out/performing the respective
checking ups, the persons responsible for
performing the quality control tests etc.
The minimum checking ups for the dose
calibrators, counters, gamma rooms,
SPECT and PET systems are shown in the
above table no.1, Appendix 4.
Radioactive sources safety
Art. 63 The authorization holder shall set
up and keep a procedure on the radioactive
sources records/inventory, movement and
storage. The procedure shall include at
least the following information:
(a) operational and general record system;
(b) necessary measures against theft, loss,
damage and unauthorized use;
(c) method and rules of taking out
radioactive sources from the storage
room, of introducing in the storage
room, monitoring of the use place;
(d) sources movements and consumption
records;
(e) responsibilities;
(f) penalties.
Radioactive sources record and
management
Art. 64 The authorization holder shall set
up and keep a primary and operational
record of all the radioactive sources used in
the practice deployment from which the
unsealed radioactive sources consumption
shall result. The radioactive sources
consumption record shall include at least
the following information:
(a) radiopharmaceutical name/radionuclide
name;
(b) activity at the manufacturing date;
(c) manufacturer and supplier of the
source;
(d) date of record;
(e) series and batch of manufacturing;
(f) storage place;
(g) date and time of movement from the
storage house;
(h) name of the persons assigned to use
them;
(i) date and time of re-entering into the
store house, if applicable.
Areas classification
Art. 65. (1) The classification of the areas
shall be carried out by a proper assessment
of the radiological risk associated to the
ionizing radiation sources use, taking into
account the potential exposure pathways.
(2) The preparing, storage rooms,
temporary storage space and the
radiopharmaceuticals injection rooms,
imagistic rooms, waiting rooms for the
patients to whom radiopharmaceuticals
were administrated for diagnostic purpose,
the wards for the treated patients treated,
17
the radioactive waste storage places shall
be classified as controlled areas.
(3) The criteria specified in Table No. 2 to
Appendix No. 4 may be used for areas
classification.
(4) Requirements for the controlled area:
(a) warning by signs provided in the
Fundamental Norms on Radiation
Safety;
(b) proper instructions at the entrance
points in the controlled areas;.
(c) existence of procedures specific to
every controlled area;
(d) access control, by:
i) administrative procedures;
ii) physical barriers with
communication systems, if
applicable;
iii) luminous and sonorous warning
systems.
(e) proper means for: changing the
clothes, contamination monitoring,
personnel decontamination, placed at
the controlled area entrance and exit.
Art. 66. (1) The area around the controlled
area is considered supervised area. The
supervised area shall be described in and
presented in the scheme of the nuclear
medicine laboratory.
(2) Requirements for the monitored areas:
(a) warning signs;
(b) visitors access control.
Art. 67 In order to prove the fulfillment of
the requirements on the supervised and
controlled areas classification, the
authorization holder shall consult a
radiation protection qualified expert that
shall certify the proposed area
classification.
Art. 68 The warning signs at every access
points shall clearly indicate the
delimitation of the controlled and
supervised areas.
Art. 69 The access and the works carried
out in a controlled area shall be allowed to
the following categories of persons:
(a) occupational exposed workers
involved in the nuclear medicine
practice deployment;
(b) persons taking care and supporting
the patients that have received
radiopharmaceuticals for diagnosis
or therapeutic purposes.
Art. 70 The authorization holder shall
ensure the persons having access to the
controlled areas the proper means for
changing the clothes, for contamination
monitoring and, as applicable, for
decontamination, placed at the entrance
and exit from the controlled area.
Requirements on the endowment of the
labs used for
the nuclear medicine practice
deployment
Sitting requirements
Art. 71 The nuclear medicine labs used for
radioactive source therapy shall be located
in special buildings or, if it is not possible,
in a completely isolated wing from the rest
of the building, at the ground floor and
with separate entrance.
Art. 72 The nuclear medicine labs used for
radio diagnosis in vivo with radioactive
sources shall be located, if possible, in a
completely isolated wing from the rest of
the rooms.
Art. 73 The nuclear medicine labs used for
radio diagnosis in vitro with radioactive
sources shall not require special location
requirements.
Art. 74 In case of placing the nuclear
medicine labs inside the buildings where
other activities are carried out as well, the
rooms where the activities specific to the
nuclear medicine labs are carried out shall
18
be located in one single part of the building
so as to ensure the labs operational circuit.
Art. 75 In case of labs using radioactive
sources for diagnosis in vivo and for
therapy, the heating installations command
units, natural gases supply, electric
installations water supply shall be placed
outside the rooms where the activity is
carried out.
Art. 76 If in the nuclear medicine lab
unsealed radioactive sources are
simultaneously used for either in vitro or in
vivo diagnosis or therapeutic purposes, the
working spaces specific to each work
category, specified in Art. 78, shall be
clearly separated.
Endowment requirements
Art. 77 The factors to be taken into
consideration for setting out the
endowment category of the nuclear
medicine laboratories, are:
(a) the annual limit of intake for the
radionuclides that are to be used,
provided in the Fundamental
Norms on Radiation Safety;
(b) type of radionuclides and the
performed operations;
(c) the risk to external exposure and
contamination, associated to types
of the involved radionuclides;
(d) treatment or diagnosis technique
type;
(e) maximum daily, weekly, monthly
or yearly activity of the working
operations.
Art. 78 The nuclear medicine lab
endowment categories represent the
allowed protection degree and are:
(a) category 1: nuclear medicine
laboratories for therapy;
(b) category 2: nuclear medicine
laboratories for in vivo
diagnosis;
(c) category 3: nuclear medicine
laboratories for in vitro
diagnosis.
Art. 79 In case of nuclear medicine labs
where unsealed radioactive sources are
used for in vivo diagnosis and therapeutic
purposes, the rooms floors, carpentry and
workplaces shall be realized so as to be
easily washed and decontaminated. For
this purpose, the following conditions shall
be complied with:
(a) the floor shall be covered with non-
absorbent materials that may be
easily cleaned and washed, resistant
to the decontamination agents
action;
(b) the floor shall be resistant to the
radiation protection shields and
shall be smooth, without cracks,
spaces, and the coupling between
the floor and the walls shall be
leaktight and rounded;
(c) the walls and the ceiling shall be
realized without any profile or
ornaments, with all angles tight and
rounded and shall be covered with
non-absorbent materials, easily
washable and resistant to the
decontamination agents action;
(d) for the doors and windows metallic
carpentry with simple profile is
recommended; the windows shall
be fixedly mounted, and the doors
shall be plane or sliding doors.
(e) the working surfaces shall be
resistant to the protection shields
weight and shall be covered with
non-absorbent materials, easily
washable and resistant to the used
decontamination agents action.
These surfaces shall be covered
with thin sheets made of absorbent
materials that shall be considered
radioactive waste after their use.
Art. 80. The furniture used in the nuclear
medicine labs shall be as simple as
possible, smooth, non-absorbent and may
easily be decontaminated.
19

Art. 81. The nuclear medicine labs used for
radioactive sources therapy shall be
provided, at least, with:
(a) rooms with niches, docks or other
ventilated and shielded precincts
according to the regulation in force
on radiopharmaceuticals
preparedness;
(b) room for radioactive sources
storage;
(c) sluice between the contamination
risk controlled areas which, function of
the works volume, shall be equipped
with:
(i) devices for shoes soles
preliminary cleaning;
(ii) a dosimetric and contamination
control point with facilities for
decontamination, wash-stand/basin
and/or shower;
(iii) a place for taking off the
contaminated protection equipment,
provided with benches and
container for the contaminated
equipment.
(d) wards with at most two beds, for
hospitalizing the treated patients,
provided with own sanitary wares,
adequate and properly shielded and
ventilation systems;
(e) room for storage and
decontamination of the patients’
underwear and bed lingerie;
(f) space for keeping and
decontamination of the plates and
dishes used by the patients;
(g) space in the patients’ wards or near
them for temporary storage of the
contaminated waste from the treated
patients;
(h) radiation protection equipments,
contamination monitoring means and
decontamination means for the medical
personnel and for the persons helping
and curing the patients, as well as their
family members;
(i) centralized dosimetric and
intercommunication system between
the patients and the medical personnel;
(j) consultations cabinet for the nuclear
medicine physician /practitioner;
(k) waste storage place.
(2) The access in the supervised area shall
be controlled so as to ensure the
continuous flux/flow, for the personnel
passing towards the rooms where the
activity is being deployed and vice versa,
one for the potentially contaminated
personnel and the other one for the non-
contaminated personnel.
Art. 82 The nuclear medicine labs where in
vivo diagnosis radioactive sources are used
shall be provided, at least, with:
(a) rooms, docks or other ventilated or
shielded places according to the
regulation in force, for preparing
radiopharmaceuticals and diluting
the radioactive substances;
(b) rooms for radioactive sources
and/or radioactive waste storage;
(c) rooms for patients injection with
radiopharmaceuticals;
(d) room for carrying out the in vivo
medical diagnostic investigations;
(e) consultation cabinet for the medical
practitioner;
(f) separated waiting rooms for the
injected and non-injected patients
with radiopharmaceuticals;
(g) showers facility for the medical
personel;
(h) dosimetric control point;
(i) technico-medical instruments
decontamination and sterilization
space;
(j) containers for collecting and
temporary storage of radioactive
waste arisen from the practice
deployment;
(k) sanitary ware for the patients to
whom radiopharmaceuticals have
been administrated, separately from
the sanitary ware of the personnel
or of the patients to whom were not
administrated
radiopharmaceuticals.
20
Art. 83 The nuclear medicine labs where in
vitro diagnosis radioactive sources are used
shall be provided, at least, with:
(a) room for storing and preparing the
solutions;
(b) niches, if works that may
contaminated the air are carried
out;
(c) a shower facility is recommended
to be ensured;
(d) room designed for radioactive
waste and/or radioactive sources
storage;
(e) frigorific space in the radioactive
sources storage place;
(f) room for processing the radioactive
biological products;
(g) space for carrying out in vitro tests;
(h) space for in vitro radiometry of the
biological products;
(i) technico-medical instruments
decontamination and sterilization
space;
(j) space for biological products
sampling.
Art. 84 If lab animals tests are necessary
in the radiopharmaceuticals treatment or
diagnosis activity, their functional circuit
shall be completely separated from the
areas used for medical activities on
humans.
Requirements on ventilation, air
decontamination and on heating
Art. 85 The nuclear medicine labs
ventilation and purifying air systems shall
prevent the pollution, including the
radioactive contamination of the air from
the working rooms and of the atmospheric
air, exceeding the maximum admitted
limits.
Art. 86 The number of the aspiration
ventilation systems shall be minimum.
Art. 87 (1) Air circulation between areas
shall be done from the non-supervised area
to the controlled area:
(2) The presure in the controlled areas
should be lower than that in the other
areas.
(3) The introduction and aspiration
apertures shall be provided with filters.
(4) The introduction and aspiration mouths
shall be placed so as to ensure efficient air
ventilation in the rooms and an easy
change of the filters.
Art. 88 In the buildings where only a part
is used for the nuclear medicine lab, the
ventilation system of the rooms in which
unsealed radioactive sources are used shall
be completely separated from the
ventilation system of the other rooms in
which no unsealed radioactive sources are
used.
Art. 89 (1) Before being released in the
atmosphere the polluted air from the
rooms, docks or niches shall be passed
through filters located as close as possible
to the contamination sources in order to
reduce at minimum the contamination of
the main air pipes.
(2) The used filters shall be disposed as
radioactive waste.
(3) The proper monitoring of the evacuated
gaseous effluents shall be ensured.
Art. 90 The nuclear medicine labs where in
vivo diagnosis and therapy radioactive
sources are used, in addition to the air
decontamination systems, shall be
provided with evacuation chimneys whose
height shall ensure an easy circulation of
the air.
Art. 91 The air re-circulation and rooms
ventilation without using mechanical
ventilation systems in the labs where in
vivo diagnosis and therapy radioactive
sources are used, is forbidden.
Art. 92 (1) The air introducing ventilators
shall be placed so that the fresh air pipes,
connected to the ventilators’ aspiration
part, shall not pass through contaminated
rooms or spaces, and the air aspiration
ventilators shall be placed so that the pipes
21
connected to the ventilators’ repression
mouth shall not pass through contaminated
rooms or spaces.
(2) The fresh introduced air shall be heated
at the proper temperature (approximately
200 C).
Requirements on water supply and
sewerage
Art. 93 (1) The nuclear medicine labs shall
be provided with cold and hot water supply
connected to the public networks.
(2) In the nuclear medicine labs where in
vivo diagnosis and therapy radioactive
sources are used, in addition to the normal
sewerage facility and separately from
thereof, a radioactive sewerage system
with two sewerages shall be provided for:
(a) radioactive effluents that need to be
conducted to treatment facility or to
storage tanks and that may
subsequently released, according to
the provisions of Art. 127 - 133;
(b) radioactive effluents that need to
be conducted to retention tanks
and, after a radioactivity levels
control is being carried out, to
verify if the provisions of Art. 127
– 133 are being complied with, in
order to be disposed to the public
sewerage or treated.
Art. 94 For the nuclear medicine labs
where in vitro diagnosis radioactive
sources are used, in addition to the normal
sewerage facility and separately from
thereof, a radioactive sewerage system for
effluents suspected of radioactivity shall be
provided.
Art. 95 The sewerage facilities and the
tanks shall be protected against corrosion.
Art. 96 (1) The tanks collecting radioactive
effluents shall be easily accessible and
ensured against radioactive fluid losses.
(2) The tanks shall be provided with
sampling equipments in view of
radioactive content analysis.
Storage
Art. 97 (1) The radioactive sources shall be
stored only in a special room where no
other products or tools necessary for the
practice deployment are stored, or in a
storage container, away from the flood
risk, assuring them against mechanical
degradation or against the harmful action
of the environment factors and that are
endowed with:
(a) system against defalcation;
(b) survey meter in the sources storage
place or radiation warning monitor;
(c) proper shields against gamma
radiation so that the dose rate in the
areas temporarily accessible for
other persons than the occupational
exposed workers (the only one that
has access in the store room) shall
not exceed 7.5 μSv/h;
(d) proper warning and fire extinction
systems, as applicable;
(e) proper ventilation systems, as
applicable.
(2) The access door to the sources storage
place or to the storage container shall be
clearly signed with “Danger of radiation”
and provided with alarm system to prevent
the unauthorised opening .
(3) In case of sources storage, a special
compartment for the safety storage of the
radioactive waste and of spent generators,
or containers shall be ensured, if a
desginated room for storage of radiaoctive
waste is not available.
Requirements on radiation protection
means and equipments
Art. 98 (1) The labs and the areas where
unsealed radiation sources are used shall
be provided, as applicable, with the
following:
(a) radiation protection means:
(i) tools used for increasing the
distance between the occupational
exposed worker and the source
(forceps, tongs etc.);
(ii) shielded containers for temporary
storage (during work) of unsealed
radiation sources;
22
 (iii) double walls containers (non-
breakable exterior wall) for liquid
radioactive samples;
(iv) trays for working with unsealed
sources;
(v) single use automatic droppers and
syringes;
(vi) shields for syringes and vials;
(vii) lead bricks or walls;
(viii) lead glass shields;
(ix) shields with Perspex for beta
radiation shielding;
(b) individual equipments:
i. for work: lab shoes and overalls,
waterproof gloves, masks, caps etc.;
ii. for radiation protection: leaded
aprons, leaded gloves, breath protection
masks in case of radiological emergencies.
(2) The used radiation protection
equipments shall be issued a type approval
authorization by CNCAN in conformity
with Law No. 111/1996, republished, with
the subsequent modifications and
completions.
Art. 99 The individual radiation protection
equipments shall be used in the areas with
contamination risks in order to protect the
wearer’s body and clothes, as well as to
prevent the contamination spreading in
other areas.
Art. 100 The individual protection
equipments shall be monitored for
contamination and removed before leaving
the controlled area.
CHAPTER VI
MEDICAL EXPOSURE
Responsibilities
Art. 101 The authorization holder shall
ensure that:
(a) no patient is exposed unless the
exposure has been prescribed by a
competent physician;
(b) the nuclear medicine
physicians/practitioners ensure the
patients radiation protection by the
prescription, as well as by the way
of administrating the dose;
(c) the exposure of the persons taking
care or supporting the patients is
subject to the dose constraints;
(d) the quality control requirements are
being met as regards the diagnosis,
by consulting a medical physics
expert;
(e) the personnel is trained as regards
the use of nuclear medicine
equipments and sources, of
radiation detection and
measurement equipments, of safety
devices and systems, according to
its position and responsibilities and
that the personnel is acquainted
with the rules applicable in case of
radiological emergency;
(f) the personnel observes the rules
and procedures applicable for the
patients radiation protection.
Justification of medical exposures
Art. 102 (1) The medical exposures shall
be motivated, taking into consideration the
benefits from the diagnosis and therapy,
the radiation exposure risk, as well as other
alternative methods that do not imply the
ionizing radiations exposure (for example,
ultrasounds or RMN).
(2) The exposure of the persons voluntarily
participating at the biomedical or medical
research, diagnosis or therapy programs
are justified only if the benefit to the
society, through the acquired knowledge, is
superior to the ionizing radiations effect on
the individual.
(3) The exposure of the persons
participating at the biomedical or medical
research programs shall be carried out
based on voluntariness, according to the
provisions of the Helsinki Declaration and
of the Norms on the radiation protection of
the persons in case of medical exposures.
Medical exposures optimization
23
Art. 103 The authorization holder shall
ensure that:
(a) the nuclear medicine physician
prescribing or managing the
diagnosis exposure:
(i) keeps the exposure at minimum
necessary to obtain the desired
information;
(ii) takes into consideration all
relevant information from the
previous exposures, in order to
avoid any additional exposures;
(iii) takes into consideration the
medical exposures reference levels.
(b) the personnel involved in medical
exposure reduces the patient’s
exposure without diminishing the
image quality, by:
(i) the proper selection of the best
radiopharmaceutical and its
activity;
(ii) using blocking methods against
radiopharmaceutical absorption in
the organs not subject to the study
and excretion accelerating methods,
respectively, as applicable;
(iii) using proper processing and
acquisition methods.
(c) the administration of
radiopharmaceuticals to pregnant
women or to possible pregnant
women shall be avoided;
(d) for breast feeding women the breast
feeding shall be stopped until the
radiopharmaceutical is no longer
excreted in the milk in quantities
assessed as bringing an
unacceptable effective dose for the
child;
(e) the radiopharmaceuticals
administration to children for
diagnosis purposes shall be done
only if there are clinical
indications, and the administrated
activity shall be reduced according
either to the weight, body surface,
or to other applicable criteria.
Art. 104 The authorization holder shall
inform:
(a) the patients on the procedure-
associated risk;
(b) the patients that have received
radiopharmaceuticals for therapy
purposes on the minimizing the
contact with the family members,
minors and pregnant or possible
pregnant women.
Diagnostic procedures
Art. 105 The authorization holder shall set
up and keep diagnostic procedures that
shall ensure, as applicable, at least the
followings:
(a) correct identification of the
patients;
(b) written protocols, for each type of
investigation, drawn up so that the
obtained information is maximum,
taking into consideration the
respective investigation reference
level;
(c) the correct recording of the
patient’s data;
(d) correct choosing of the acquisition
conditions so as to get the best
image quality (choosing the
collimator, absence of collimator’s
contamination, energy/power
window, acquisition matrix size,
acquisition time, collimator’s
leaning, SPECT parameter, PET,
zoom factor);
(e) reducing the dose for thyroid by
using thyroid blocking agents, as
applicable;
(f) avoiding the radioactive
concentration increase in the
working room by exterior
elimination or collecting on filters
or in a leak-proof container in cases
when radioactive gases such as
133
Xe or aerosols are administrated;
(g) protection against external
contamination of the patients
receiving orally or by inhaling
radioactive substances, by
providing a plastic apron for
clothes protection;
24
 (h) the effective dose to the foetus or
breast-feeded child, as results of the
medical exposure of the mother is
smaller than 1 mSv;
(i) notifying or orally informing the
persons that have been
administrated radiopharmaceuticals
and their accompanying persons, on
the necessary precautions and on
the risk, in case of administration of
an activity exceeding 300 MBq of
131
I.
Art. 106. The authorization holder shall:
(a) ensure that the reference levels for
the medical exposures are set out
and complied with, in conformity
with the provisions of the Norms
on radiation protection of the
persons in case of medical exposure
and that they are used by the
medical personnel involved in the
practice deployment;
(b) corrective measures are required in
case the doses and activities are
under the reference levels and,
consequently, the exposures do not
offer a good information for
diagnosis so that they do not lead to
a benefit for the patient;
(c) require the procedures review if the
used activities exceed the reference
levels, in view of ensuring an
optimized protection of the patient
and maintaining the proper levels
for a good practice.
Therapeutic applications
Art. 107 The authorization holder shall set
up and keep procedures applicable in
therapy that shall ensure, as applicable, at
least the followings:
(a) correct identification of the patients;
(b) correct registration of the patient’s
data;
(c) notifying and orally informing the
patients on the measures necessary to
minimize the public and family
members exposure;
(d) preventing the contamination
spreading by vomit or excreta;
(e) limitation and observance of the
patients’ movements, during
treatment, by the dosimetric system
installed in the controlled area;
(f) necessary conditions so that the
effective fetus dose, following the
medical exposure of the mother, is
smaller than 1 mSv;
(g) written instructions to the patients
regarding the conception after the
unsealed sources therapy;
(h) rules for patient releasing after
therapeutic dose administration.
Breast-feeding
Art. 108 (1) The authorization holder shall
check up if a woman patient breast feeds
before starting any nuclear medicine
procedure. In case the patient breast feeds,
a special attention shall be paid to the
medical exposure optimization and
justification, taking into consideration the
mother’s exposure, as well as the child’s
exposure.
(2) The authorization holder shall give to
the patient written recommendations on the
necessity of breast feeding cessation.
(3) The recommendations shall ensure the
effective dose received by the child is
smaller than 1 mSv.
(4) The breast feeding shall be stopped
during the therapy with unsealed
radioactive sources.
(5) The Table No. 3 from Appendix No. 4
may be used in order to recommend the
time periods of ceasing the breast feeding.
For other radiopharmaceuticals than those
mentioned in the table, the medical physics
expert shall drawn up written procedures
that shall be subject to CNCAN’s approval.
Conception after unsealed sources
therapy
Art. 109. (1) The authorization holder shall
give the patients written recommendations
25
on the time periods for avoiding the
conception after unsealed sources therapy.
(2) After an unsealed sources treatment, the
woman patient shall be informed in written
on avoiding getting pregnant for a proper
time period.
(3) The recommendations shall ensure the
effective dose received by the child is
smaller than 1 mSv.
(4) The Table No. 4 from Appendix No. 4
may be used in order to recommend the
time periods for avoiding the pregnancy.
For other radiopharmaceuticals than those
mentioned in the table, the medical physics
expert shall drawn up written procedures
that shall be subject to CNCAN’s approval.
Art. 110 (1) For the men patients the
conception shall be avoided for 6 months
after the treatment, in case of 131I, 32P
phosphate or 89Sr chloride therapy.
(2) For other radiopharmaceuticals than
those mentioned in paragraph (1), the
medical physics expert shall drawn up
written procedures that shall be subject to
CNCAN’s approval.
Clinical dosimetry
Art. 111 (1) The authorization holder shall
set up and keep a clinical dosimetry
procedure ensuring that:
(a) the physical parameters and the
prepared radiopharmaceuticals
quality in view of diagnosis or
treatment are checked up;
(b) the activity to be administrated
is measured and recorded in the
moment of administration for
the diagnosis procedures;
(c) the doses absorbed by the
relevant organs and the
effective dose are determined
and documented for the activity
to be administrated according to
the clinical protocol;
(d) the doses absorbed by the
relevant organs and are
determined and documented in
the therapy case.
(2) The authorization holder shall consult a
medical physics expert in view of drawing
up the procedure provided in paragraph 1
of this article.
Dose constraints
Art. 112 The authorization holder shall
apply constraints to any dose received by
the persons taking care of and supporting
the patients, as well as by the family
members the patients. The applied
constraints shall not lead to doses
exceeding the following values:
(a) 1 mSv for children and for
embryo/fetus;
(b) 3 mSv for adults up to 60 years old;
(c) 15 mSv for adults over 60 year old.
The maximum activity at which the
patients may be released from hospital
Art. 113 (1) The patients that have received
a treatment with radiopharmaceuticals may
be released from hospital only if the
effective doses received by the family
members and by other persons involved in
their caring of, caused by the residual
activity, do not exceed the dose constraints
set out according to Art. 112.
Art. 114 (1) The authorization holder, by
consulting a medical physics expert, shall
set out/establish a procedure for releasing
the patients to whom radiopharmaceuticals
have been administrated for therapy
purposes. The procedure shall prove that
the dose constraints provided in art. 112
are being complied with and it shall
include, at least, the followings:
(a) setting out the level for the residual
activity or of the dose rate measured
at 1 m from the patient, over which
the patients may be released;
(b) the measuring protocol;
(c) written instructions that shall be
handled to the patient upon releasing
from the hospital and the time period
for which these instructions need to
be followed;
26
 (d) record of the measurements carried
out upon release from the hospital.
(2) The written instructions provided in
paragraph (1), letter (c) of this article shall
include, at least, the following aspects, as
applicable:
(a) the minimum distance to be kept
between the patient and the family
members or other persons with
whom the patient comes into
contact; for example: minimum 1
m for short time periods, minimum
2 m for time period over 1 hour;
(b) the distance to be kept between the
patient and the pregnant women;
(c) the behavior of the patient towards
the children up to 10 years old; for
example: avoidance as much as
possible of the contact with them;
children under 2 years are
recommended not to live with the
patients treated with
radiopharmaceuticals for a definite
time period;
(d) use of the sanitary
objects/equipments, plates etc.;
(e) pregnancy avoiding time period;
(f) breast feeding ceasing time period;
(g) conditions under which the patient
may resume the work;
(h) avoidance of crowded places;
(i) public transport restrictions;
(j) special circumstances when the
information of the medical
personnel involved in subsequent
medical treatment/assistance of the
patient treated with
radiopharmaceuticals: emergency
operations, other medical attending
etc.
(3) The Table No. 5 from Appendix No. 4
may be used in view of setting out the time
periods recommended to follow the written
instructions received by the patient treated
with 131I, upon release from hospital.
Art. 115 (1) The authorization holder shall
promptly investigate the following
situations:
(a) any treatment wrongly
administrated to another patient,
with another radiopharmaceutical
or with a dose or dose fraction
distinct form the one prescribed by
the physician and that may lead to
serious side effects;
(b) any exposure for diagnosis purpose
higher/smaller than the prescribed
one or that leads to taking over the
procedure, thus significantly
increasing the set reference levels;
(c) any failure or malfunction of the
equipments, any accident, error or
other unforeseen situation that may
lead to a significant exposure of the
patient exceeding the prescribed
one.
(2) In all the abovementioned situations the
authorization holder shall consult a
qualified expert in order to:
(a) calculate and assess the received
doses and their distribution in the
patient’s body;
(b) indicate and implement the
corrective measures necessary to
prevent the recurrence of these
situations;
(c) submit to CNCAN and to the
Public Health Bureau, as soon as
possible after the investigation, a
written report on the incidents
causes.
Medical investigations
Art. 116 The authorization holder shall
keep for a 10-year time period the
information on the radiopharmaceuticals
type and on the activities administrated to
the volunteers participating at the research
programs.
Art. 117 The clinical observation sheet of
the patients treated with
radiopharmaceuticals shall include a least
the following compulsory data:
(a) the administrated radiopharmaceutical,
administration method, activity and
administration date;
27
(b) the name of the person carrying out
the administrated activity control,
control method and the data necessary
to identify the respective deliver of
radiopharmaceutical;
(c) record of the measurements carried out
upon release from the hospital.
Population exposure
Art. 118 The access of the persons
participating at the patients’ support and
assistance, as well as the access of their
family members in the controlled and
supervised areas shall be controlled.
Art. 119 The persons participating at the
patients’ support and assistance, as well as
the access of their family members shall be
accompanied in the controlled areas by a
person trained on the safety and radiation
protection measures of the respective area
and shall be informed on the rules they
have to observe.
Art. 120 (1) The existence of a screen or a
lead glass in the patient’s ward is
recommended in order to ensure the
radiation protection of the persons
participating at the patients’ support and
assistance, as well as their family
members.
(2) For the dose control of the persons
participating at the patients’ support and
assistance, as well as of their family
members, individual dosimeters (digital,
with direct reading etc) shall be used, and
the received dose shall be recorded at
every visit and for every visitor.
Art. 121 In case the patients to whom
radiopharmaceuticals were administrated
for therapeutic purposes need to undergo a
surgery, measures necessary to prevent the
radioactive contamination of the surgery
room, of the medical personnel and of the
tools shall be taken.
Art. 122 After the ending of the surgery,
the person responsible for radiological
safety shall ensure the used tools and the
medical personnel contamination control.
Art. 123 (1) The dead bodies with an
activity of at most:
(a) 1 MBq of 131I;
(b) 0.1 MBq of 90Y;
(c) 0.1 MBq of 32P
may be incinerated/embalmed without
special radiation protection measures.
(2) For other radiopharmaceuticals than
those mentioned in paragraph (1), the
medical physics expert shall draw up
written procedures that shall be subject to
CNCAN’s approval.
Art. 126 (1) The framing in the conditions
provided in art. 123 shall be certified in
written by the the medical physics expert
and by the person responsible for radiation
protection (RPO).
(2) The record of the certificates issued in
conformity with the provisions of
paragraph (1) of this article shall be kept
by one of the persons responsible for
radiation protection assigned for the
nuclear medicine laboratory.
Art. 125 (1) The autopsy, the post-mortem
anatomic-pathological examinations, the
embalming or incinerating authorizations
shall be issued by the Public Health
Bureau.
(2) The evidence of the certificates issued
in conformity with the provisions of
paragraph (1) of this article shall be kept
by the emitter.
Radioactive waste
Art. 126 At least the followings are
considered radioactive waste arisen from
the nuclear medicine practice deployment:
(a) sealed radioactive sources that
have been used for testing, quality
control and equipments calibration;
(b) spent radionuclides generators;
(c) excreta from the patients treated
with unsealed radiation sources;
28
 (d) prepared solutions that have been
used for diagnostic and therapy
purposes;
(e) liquid waste with very low
radioactivity (for example, from
the washing machines);
(f) liquid immiscible with the water
(scintillation liquids);
(g) solid waste: pipettes, syringes used
for radionuclides with relative long
variation time (32P), filters;
(h) solid waste with very low
radioactivity: syringes, pipettes,
glass, vials or other items arisen
from decontamination;
(i) radioactive gases;
(j) incineration ashes;
(k) waste arisen from medical
research.
Art. 127 Radioactive substances, including
contaminated substances, materials and
objects arisen from the nuclear medicine
practice may be released from the regime
of the requirements of the Fundamental
Norm on Radiation Safety, only if the
specific activity/activities concentration
values have reached values smaller or at
most equal to the levels released from the
authorization requirements, set out by
CNCAN in these Norms.
Art. 128 The radioactive contaminated
waste, as well as the ionizing radiation
sources that can no longer be used in the
nuclear medicine practice, having the half
time up to 100 days, may be collected and
temporarily stored until they have reached
values smaller or at most equal to the
levels released from the authorization
requirements, set out by CNCAN in these
Norms.
Art. 129 (1) The solid waste are considered
radioactive waste only if the activity given
by the radionuclides emitting beta or
gamma radiations exceeds 10 kBq/kg and
the radionuclides emitting alpha radiations
exceeds 1 kBq/kg. The activity may be
averaged for a waste quantity that does not
exceed 10 kg.
(2) The solid waste that are not considered
radioactive waste, according to the criteria
from paragraph 1 may be treated as
laboratory usual/common waste.
Art. 130 The solutions containing
scintillation liquids or other waste
containing organic solvents are considered
radioactive waste in the following cases:
(a) the radioactive concentration does
not exceed 10 Bq/ml and there are
no alpha emitting radionuclides;
(b) the radioactive concentration does
not exceed 100 Bq/ml and there is
only 14C or 3H.
Art. 131. (1) The activity limits for the
radioactive substances that may be released
in the sewerage system are the followings:
(a) the maximum total activity that may be
released in the sewerage system in a single
release complies with the condition:
Ak
 ALI
k
 2,5
min, k
(b) the maximum total activity that may
be released in a month complies with the
condition:
Ak
 ALI
k
 25
min, k
where:
Ak represents the K
radionuclide activity;
ALI min,k represents the smallest
value calculated for the annual
receiving limit of K radionuclide.
(2) In Table No. 6 from Appendix No.
6 the values ALI min are
recommended for the most used
radionuclides. For calculation of
ALI min for other radionuclides,
the dose limits and the effective
doses per receiving unit from the
Fundamental Norms on
Radiation Safety shall be used.
29
 Art. 132 (1) The gaseous
radioactive substances emission
into the environment shall
comply with the relation:
Ck

k CMAk
1
where:
Ck represents k radionuclide
activity concentration;
CMAk represents the maximum
admitted concentration for K
radionuclide and is equal to 1%
from the k radionuclide
concentration derived into the air.
(2) In Table No.7 from Appendix
No. 4 the CMA values for the
most used radionuclides are
recommended. For the calculation
of the concentration derived into the air /
CMA , for other radionuclides, the dose
limits and the effective doses per receiving
unit by inhalation from the Fundamental
Norms on Radiation Safety shall be
used.
Art. 133 (1) The solid waste with low
radioactivity may be delivered as usual
waste, including for incineration, if the
following conditions are fulfilled:
(a) the activity of a single waste
container does not exceed 2,5
ALI min and the dose rate at
the container surface is up
to 5Sv/h;
(b) the maximum delivered
activity by a nuclear
medicine lab in a month
does not exceed 25 ALI min ;
(c) the maximum delivered
activity in a year does not
exceed 100 GBq;
(d) if the waste contain
different radionuclides, the
realtions specified in art.
131 shall be complied with.
(2) The waste to be delivered as
usual waste, including in view of
incineration, shall not contain
sealed radioactive sources with
activity higher than the
exceptance levels set out in the
Fundamental Norms on Radiation
Safety.
(3) The sealed radioactive sources
that cannot delivered as usual waste
may be delivered to the authorization
holder authorized by CNCAN for
collecting and disposal as radioactive
waste or shall be returned to the producer.
Art. 134. The authorization holder shall set
out and maintain a primary and operative
evidence of all the resulted radioactive
waste types – liquid, solid, gaseous. The
record shall contain at least the following
information:
(a) waste type;
(b) radiopharmaceutical/radionuclide
name;
(c) waste activity at the
disposal/storage date;
(d) storage place;
(e) waste activity at the
delivery/environment release date;
(f) the name of the authorization
holder authorized by CNCAN to
whom the waste have been
transferred, if applicable;
(g) the name of the person responsible
for radiation safety and of the
person that has delivered or
released the radioactive waste.
Art. 135 The authorization holder, with the
help of the radiation protection qualified
expert, shall set up and keep a procedure
on the radioactive waste collecting,
treatment and disposal method, arisen from
the nuclear medicine practice, that shall:
(a) ensure that the activity and the
volume of all the radioactive waste
arisen from the sources he is
responsible for, are kept at a level
as small as possible and that the
radioactive waste are managed in
conformity with CNCAN
requirements.
(b) ensure that the radioactive waste
disposal in the public sewerage or
30
 waste systems is carried within the
limits provided by CNCAN.
(c) keep the responsibilities he has as
regards the sources until the
moment provisions for sources
transfer to an authorized holder or
to a radioactive waste disposal and
treatment unit are issued.
CHAPTER VI
RADIOLOGICAL EMERGENCIES
INTERVENTION PLANNING AND
PREPARING
Art. 136 (1) The authorization holder shall
identify the incidents/accidents that may
affect the occupational exposed workers
and/or the population and shall draw up an
emergency procedure.
(2) The emergency procedure shall include
the intervention plans for identified
radiological emergencies.
(3) The authorization holder may contract
the carrying out of the radiological
emergency intervention with an authorized
intervention body. The contract shall
clearly provide the responsibilities of both
parties.
Art. 137 The events for which emergency
plans shall be elaborated are the fire,
natural calamities (floods, earthquakes)
and, as applicable, the followings:
a) breaking of the vial with unsealed
sources or of the 99Tc generator vial;
b) loss of sources in the lab space;
c) areas accidental contamination;
d) breaking of the radioactive waste
tanks or of the ones suspected of
radioactivity;
e) administration to the patient of an
activity higher than the one established
by the reference levels.
Intervention plan
Art. 138 (1) In order to draw up an
intervention plan a radiation protection
qualified expert shall be consulted.
(2)The radiation protection qualified expert
shall approve the intervention plan.
Art. 139 The intervention plan shall
contain at least the followings:
(a) identification of potential accidents
and of other events that may occur
during the nuclear medicine
practice deployment and their
associated potential risks
assessment;
(b) identification of all authorized
persons to participate at different
phases of intervention;
(c) identification of all the persons or
bodies to be notified in case of
incident, including the possibility
of contacting these persons
(telephone, fax, e-mail, addresses);
(d) indications on the method of
recognizing the moment when a
certain intervention plan needs to
be implemented;
(e) specific specifications for each
identified emergency situation;
(f) specific specifications to be
followed in case of risk of human
lives losses;
(g) identification and acquisition of
equipments and means necesssary
for the intervention;
(h) specifications on panic removal,
forbidance of touching the sources
with the hand, withdrawal at
distance, planning the following
phases and their implementation,
limitation to intervention measures
that are in accordance with the
experience degree and with the
competence, soliciting the technical
assistance or support.
Art. 140 (1) The person responsible for
radiation protection (RPO) shall be liable
for the concrete application of the
approved intervention plan.
(2) Intervention exercises for the approved
intervention plan application and
implementation shall be periodically
carried out.
31
(3) Records of the carried out exercises and
of the received doses shall be kept.
Art. 141 Prior to the intervention, the
intervention participants shall be informed
on the health risks and shall accept in
written the particiaption at the intervention.
Identification and acquisition of the
equipments and means necessary
for the intervention
Art. 142 The minimum endowment of the
radiological equipments with radioactive
sources necessary for the intervention
includes:
(a) proper radiation sources handling
devices;
(b) proper dosimetric control devices;
(c) proper warning signs and physical
barriers;
(d) lead shields used for the used
sources;
(e) proper means for decontamination;
(f) proper container for the produced
waste storage.
Personnel training in view of
intervention plan implementation
Art. 143 All the persons assigned to
participate at the interventions shall
be designated, in written, and shall
be properly trained to comprehend
the intervention plan content and to
correctly use the equipments and
means necessary for the intervention.
Art. 144 The knowledge of the personnel
assigned to participate at the interventions
shall be checked up at regular time periods
that shall not be higher than 6 months.
CHAPTER VII
ACCIDENTS REPORT
Art. 145 The accident report shall be drawn
up by the person responsible for radiation
protection (RPO), with the collaboration of
a radiation protection qualified expert.
Art. 146 The report shall include:
(a) the detailed description of the
accident;
(b) identification of the involved
persons and equipments;
(c) accident’s causes, if known;
(d) measures taken for re-establishing
the situation;
(e) doses received by the affected
personnel;
(f) recommendations on the measures
to be taken in order to prevent
reoccurrence of similar situations.
CHAPTER VIII
OTHER NOTIFICATIONS AND
REPORTS
Art. 147 (1) The authorization holder shall:
(a) immediately notify CNCAN on
any radiological incident or
accident by means of a report
drawn up in conformity with the
provisions of art. 145 and art. 146;
(b) immediately notify CNCAN and
the local medical-sanitary
authority, the Public Health Bureau
– Ionizing Radiations Hygiene
Laboratory on any exposure of the
patient to a dose higher
than/exceeding the prescribed
dose;
(c) immediately notify CNCAN and
the local police on any radioactive
sources loss or defalcation, by
means of a report in which the
occurrence circumstances,
quantities, form, content and risk
that may appear shall be described.
(2) The authorization holder shall submit to
the competent authorities, within 10 days
from the occurrence date, a written report
on the event.
32
 CHAPTER IX
FINAL AND TRANSITORY
PROVISIONS

Art. 148 The authorization application

form presented in the Appendix No. 2 to
these Norms may be used as an alternative
to the form No. 4 – Authorization
application form for the activity of the
Norms on radiation safety – Authorization
procedures.
Art. 149 Within one year from the date of
entering into force of these Norms the
authorization holders shall take the
measures necessary for the setting up and
implementation of the operational radiation
protection system.

Art. 150 The persons with high specialty

studies that hold a level 2 exercising permit
valid for “unsealed sources” field, “other
applications” specialty may carry out their
activity of medical physics experts in the
nuclear medicine laboratory, until the date
of entering into force of the regulation on
medical physics experts assignation.

Art. 151 Starting with the date of entering

into force of these Norms any other
provisions on the safety deployment of the
ionizing radiations nuclear medicine
practice shall be repealed.

33
 APPENDIX No. 1
Radiation protection legislation in the nuclear medicine practice

1. Law No. 111 from 10th of October 1996 on the nuclear activities safety deployment,
- published in the Official Journal of Romania No. 267 from 29 th of October
1996;
- republished in the Official Journal of Romania No. 78 from 18th of February
1998 (Law No.16/1998).
2. Government Emergency Ordinance No. 204/2000 on the modification of Law No.
111/1996 on the nuclear activities safety deployment, published in the Official Journal of
Romania, Part I, No. 589, on 21 of November 2001, approved by Law No. 384/2001.
3. Law No. 193 on the modification and amendment of Law No.111/1996 on the nuclear
activities safety deployment, published in the Official Journal of Romania, Part I, No. 343
from the 20th of May 2003.
4. Normative on granting and use of the ionising radiations individual protection equipment
RP 06/1997, approved by MAPM Order No. 318 of the 23rd of April 1997 and published
in the Official Journal of Romania No. 111 bis of the 4th of June 1997.
5. Norms on notified bodies designation for the nuclear field, approved by Order of the
CNCAN President No. 219 of 10th of December 1999 and published in the Official Journal
of Romania No. 87 from 28th of February 2000.
6. Fundamental Norms on Radiation Safety approved by Order of the CNCAN President No.
14 of 24th of January 2000 and published in the Official Journal of Romania No. 404 bis
of the 29th of August 2000.
7. Norms on radiation safety on the radiation protection of the occupational exposed
workers, approved by Order of the CNCAN President No. 353 of 20th of August 2001 and
published in the Official Journal of Romania, Part I, No. 764 bis of 30 th of November
2001.
8. Norms on radiation safety – Authorization procedures, approved by Order of the CNCAN
President No. 366 of 22nd of September 2001 and published in the Official Journal of
Romania, Part I, No. 764 bis of 30th of November 2001.
9. Norms on radiation protection of the ionising radiation medical exposed persons,
approved by joint Order of the Minister of Health and Family and of the President of
CNCAN No. 285/79/2002 and published in the Official Journal of Romania, Part I, No.
446 bis of the 25th of June 2002.
10. Norms on individual dosimetry approved by Order of the CNCAN President No. 180,
published in the Official Journal of Romania, Part I, No. 769 bis of the 22 nd of October
2002.
11. Norms on issuing of the nuclear activities exercising permits and on the assignment of the
qualified experts in radiological protection, approved by Order of the CNCAN President
No. 202 of the 15th of October 2002 and published in the Official Journal of Romania, Part
I, No. 936 bis of the 20th of December 2002.
12. Fundamental Norms on the radioactive materials safety transport approved by Order of
the CNCAN President No. 373 of the 3rd of October 2001, published in the Official
Journal of Romania No. 137 bis of 21st of February 2002.
13. Norms on the radioactive materials transport – Authorization
procedures, approved by Order of the CNCAN President No. 222/2002, published in the
Official Journal of Romania, Part I, No. 8 of the 9th of January 2003.

34
14. Regulation on the nuclear activities control and authorization taxes and tariffs, edition in
force, approved by Order of the CNCAN President and published in the Official Journal
of Romania, Part I.
APPENDIX No. 2

MODEL OF TECHNICAL DOCUMENTATION FOR UNSEALED RADIOACTIVE

SOURCES USE IN MEDICINE

APPLICATION TYPE:
 Initial application form
 Modification of authorization
 Reauthorization

AUTHORIZED ACTIVITIES
 Sitting – Construction
 Use

It shall refer to the previous application forms, communicating the application form (forms)
registration date and number or the number of the previous authorization (authorizations).

The authorization holder shall communicate to CNCAN the following information, excepting
the case when the source is excepted from the authorization process.

I – GENERAL INFORMATION

I – 1. Identification data of the applicant: name and address

Headquarters:………………….
Address: ……………………….
Working point:……………..
I – 2. Identification data of the qualified personnel:
a. Person responsible for radiation safety:
Name and surname:
Job position:
Professional experience/training:
Number of the exercising permit:
Telephone:
b. Nuclear medicine physician:
Name and surname:
Job position:
Professional experience/training:
Number of the exercising permit:
Telephone:
c. Chief medical assistant:
Name and surname:
Job position:
Professional experience/training:
Number of the exercising permit:
Telephone:

35
 d. Medical physics expert:
Name and surname:
Job position:
Professional experience/training:
Number of the exercising permit:
Telephone:
e. Radiation protection qualified expert:
Name and surname:
Job position:
Professional experience/training:
Number of the exercising permit:
Telephone:
I – 3. Person that legally contracts the applicant’s liability:
Name and surname:
Job position:
Telephone/Fax/E-mail:
I – 4. Date proposed for installation (mounting)/placing into operation of the equipments and
endowments:
……………………………….
SIGNATURE/STAMP
………………………………………………
Signature of the person representing the legal body:
Job position:………..
Date:…………….

II – RADIOACTIVE SOURCES

II – 1. Details on the radionuclides involved in nuclear medicine laboratory activity:

Radionuclide/ Maximum Physical/chemic Use

radiopharmaceuti activity al form
c (Bq)
(e.g. Generator of (e.g. 37 Na99mTcO4 Medical
99m
Tc) GBq) imagistics

II – 2. Ionizing radiations sources reception:

Description of the unsealed sources parcels, upon receiving. Any special characteristics, such
as storage container pressurizing or if it includes protection shields, shall be specified.

……………………………………….

II – 3. Working process:
Specify the unsealed radiation sources/radiopharmaceuticals receiving frequency.
…………………………

II – 4. Working points:

36
Shall the working process be carried out at Unknown Yes No
an address different from that
mentioned at poin I – 1 ?

Note: The Commission may request the notification prior to the beginning of the working
process at a different address from the specified one.

Indicate the addresses of all the working points:…………………….

II – 5. Radioactive waste:
Specify if the activity type you are deploying may generate radioactive waste and offer an
estimation of the different waste forms:

Radionucli Waste type Maximum Proposal for waste

de Activity (Bq) evacuation
E.g: I-125 Liquid 10 KBq Drainning
Tc 99m Used 2 MBq Radioactive waste storage
syringes

III – ENDOWMENTS AND EQUIPMENTS

Description of the endowments/arrangements and of the equipments used in the nuclear

medicine laboratory, including:

III – 1. Arrangements specifications:

1. Detailed description of the location where the nuclear medicine laboratory shall be located.
2. The lab sitting project clearly indicating the areas/rooms for: used radiation sources deposit,
radiopharmaceuticals administration, imagistic rooms and rooms where the counting system is
(for in vitro diagnosis), as well as the wards for the patients treated with unsealed radiation
sources. The ________of the sinks, showers, toilets, etc, shall be directly connected to the
draining sanitary system. The drawings of the arrangements or a detailed sketch including the
material type used at the ceilings and floors construction, as well as their thickness.
3. Describe all the means used in view of limiting the radioactive contamination extension on
the surfaces or in the air. Specify the characteristics of the surfaces, floors, walls, equipments
and furniture.
4. Indicate the endowment category proposed to the laboratory.

III – 2. Equipments specifications:

1. Specify the producer’s indications (commercial name, model, series, manufacturing year,
technical specifications, etc.) and the radiation safety authorization number for the imagistic
equipment to be used.
2. Specify the producer’s indications (commercial name, model, series, manufacturing year,
technical specifications, etc.) and the radiation safety authorization number, as well as the
validation certification type for the calibration and activity measurement equipment.
3. Describe the arrangements proposed for the exposure restriction, as it follows:
- the method by which the ionizing radiation external exposure protection is
ensured (e.g. protections for syringes and vials etc.)

37
 - ventilation system to reduce the internal contamination risk for the personnel,
if applicable;
- the declaration sustaining that the decontamination arrangements are easily
accessible;
- any radiation protection and protection equipment type that shall be ensured
for the personnel, as well as for the patients. For the radiation protection
equipments, specify the radiation safety authorization number;
- description of any equipment by means of which the radioactive sources may
be handled from the distance.

IV – OPERATIONAL RADIATION PROTECTION PROGRAM

Describe the operational radiation protection program, including:

IV – 1. Organizational structure
a) Describe the organization and management system, including the
responsibilities assignation. Particularly, include the followings: personnel
training level, equipments acquisition, other functions of the person
responsible for radiation safety, the requirement according to which the person
responsible for radiation safety shall report to the authorization holder the use
under unsafe conditions of the radioactive sources and equipments, the
personnel training program, evidence of all the records, methods based on
which the problems affecting the safety are identified and corrected.
b) Identify the personnel that shall be involved in working with radiation sources,
including the persons responsible for radiation protection: name, training,
studies, experience, qualifications.

IV – 2. Monitoring of the working place, classification of the areas and the individual
monitoring.
a. Describe the monitoring program of the working place, including: measures to
be measured, frequency, measurement procedures and methods, action levels
and the measures taken in case of exceeding these levels;
b. Describe the areas classification method;
c. Describe all the personal dosimeters types, which the occupational exposed
workers are equipped with. Describe the individual doses review method,
including the action levels and the measures taken in case of exceeding these
levels;
The name and address of the individual dosimetry certified body:
………………………………….
Name the individual dosimeters type:
i. film
ii. thermo luminescent dosimeter (TLD)
iii. direct reading digital dosimeter
iv. other
d. Describe the internal dosimetry form you ensure, if applicable:……………

IV – 3. Local and surveillance/monitoring rules of the radiation sources work

a) Describe your local rules and procedures with regard to: the investigation levels or
other authorized levels, protective measures and safety provisions, supervision

38
 measures, the method of providing the workers with information regarding health
risks due to occupational exposure to ionising radiations, and instructions on
radiological emergncy situations.
b) Provide copies of your operational procedures on: access control in the classified
areas and in the shielded rooms, inventory of the radioactive sources and
contamination measurement tests, etc .
c) Describe your training programme, drawn up in such a way, that all appropriate
personnel be adequately trained, aware of the correct operating procedures and the
way how their actions may affect the radiological safety.
d) Describe your policies with regard to pregnant occupationally exposed female
workers (notification, adoption of working conditions to protect foetus/embryo) and
the instructions you will provide them with.
e) Describe your programme on health surveillance of occupational exposed workers.

IV – 4. Quality assurance
(a) Describe the program in order to make sure the safety requirements are being
complied with.
(b) Describe the procedure review, current procedures maintaining program, the
procedures modification process and the method they are place at the
personnel’s disposal.
(c) Describe the public and professional exposure optimization program to levels
as low as possible and reasonably to be realized.
(d) Describe the service method for the equipments used in the nuclear medicine
laboratory (authorized units, medical physics experts).

IV – 5. Radioactive materials transport

If you transport or ship radioactive waste or radiopharmaceuticals, describe the arrangements
made for the transport and preparedness of the parcels containing radiation sources. These
procedures shall include: documentation on parcels certification, measuring on the dose rates
given by the parcels, the delivery/receiving documents, other details on shipments
preparedeness.

IV – 6. Radiological emergency procedures

Supply/specify the emergency procedures set out in view of preventing the potential
exposures, such as: radioactive sources loss/defalcation, radioactive material scattering, the
exposures, significantly higher than the intended ones, of the patients and the significant
accidental exposures of the occupational exposed workers. If other emergency situations are
being identified, supply the additional procedures necessary in these cases, as well.

IV – 7. Transfer or waste disposal of the radioactive sources

Describe the arrangements made in view of radioactive waste transfer/disposal.

IV – 8. Record system, including:

 Radioactive waste management;
 Personnel exposure
- current records;
- previous data on exposure.
 Monitoring of the workplace
- external exposure to ionizing radiations;

39
 - surfaces contamination.
 Calibration and checking up tests for the used instruments;
 Radioactive sources inventory;
 Audits;
 Radiation protection program review;
 Investigations reports on radiological incidents/accidents;
 Evidence of the occupational exposed workers health state surveillance.
 Transport.

V. MEDICAL EXPOSURE

Describe the medical exposures control program, including:

V – 1. Responsibilities for medical exposure

a) Describe your arrangements to ensure that patient examination in view of
diagnosis/treatment will be prescribed only by medical practitioners.
b) Describe criteria and arrangements to ensure an adequate number of trained medical
and paramedical personnel to discharge assigned tasks.
c) Describe your arrangements to assure that the imaging and quality assurance
requirements are fulfilled with the advice of a qualified expert in nuclear medicine
practice.

V-2. Justification of medical exposures

a) Describe your organisatory measures, set out in order to ensure that the benefits of the
applied radiological imagistic methods outweigh the radiation detriment which it may
cause, taking into account the benefits and risks of available alternative techniques that
do not involve ionizing radiations.
b) Describe, if applicable, the method according to which you confirm that exposure of
humans for medical research, if performed, will always be in accordance with the
Helsinki Declaration and will always follow the guidelines of application prepared by
the Council of the International Organizations of Medical Sciences and the World
Health Organisation, respectively.
c) Describe, if applicable, the method according to which you confirm that each exposure
of humans for medical research, if performed, is subjected to the notification of an
Ethical Review Committee according to the specific regulations of the Ministry of
Health.

V – 3. Radiation protection optimization

Operational considerations
(a) Describe the requirements set out for the practitioners so as to ensure the
patients exposure is the minimum necessary exposure in view of obtaining the
diagnosis information and that all the relevant information arisen from
subsequent examinations are taken into consideration in view of avoiding
unnecessary additional examinations.
(b) Describe the method you ensure that the practitioner, technicians and the
personnel involved in imagistics use all the available means and knowledge in
view of obtaining an acceptable quality of the image by minimum exposure of
the patient by:

40
 - properly selecting the radiopharmaceutical and its activity, and writing down
the special requirements for children and patients with some organs
malfunctions;
- using methods of blocking the absorption into the organs that are not subject to
the study and by excretion accelerating methods, as applicable and wherever
possible;
- acquisition and proper processing of the image.
(c) Confirmation that the procedures causing the exposure of the women that are
or might be pregnant, are avoided, excepting the cases where there are solid
clinical evidences.
(d) Describe the method by means of which you ensure that for the breast feeding
mothers recommendations have been made on ceasing the breast feeding until
the radiopharmaceutical is no longer present in the milk in a quantity estimated
to give a dose unacceptable for the child.
(e) Describe the method by means of which you ensure that the administration of
radiopharmaceutical to children in view of diagnosis shall be carried out only
if there are solid clinical indications and if the activity shall be reduced taking
into account the weight, body surface or other proper criteria, according to
Norms on radiation protection of the persons in case of medical exposures.

V – 4. Calibration
(a) Describe the method by means of which you ensure the calibration of the radioactive
sources used in medical exposures and the condition that it shall be ______ at a standard
dosimetry laboratory.
(b) Describe the method by means of which you ensure the unsealed radioactive radiation
sources are calibrated in terms of activity for the radiopharmaceutical to be administrated and
that at the moment of administration the activity is determined and record.

V – 5. Clinical dosimetry
Describe the method by means of which you ensure that in the treatment and diagnosis with
unsealed radioactive radiation sources, the doses absorbed by the patient’s organs are
determinated and documented.

V – 6. Quality assurance
Confirm if the quality assurance program for the medical exposures includes:
(a) Physical parameters checking up measurements upon placing into operation (results of the
acceptance tests) and regularly afterwards.
(b) Written records of the relevant procedures and of the checking up measurements results;
(c) Checking up the proper calibration and the operation conditions for the monitoring and
dosimetry equipments;
(d) Checking up the patient’s identity.

V – 7. Dose constraints
Describe your procedures in order to ensure that the dose received by any patient helper is
subject to dose constraints.

V – 8. Investigation of accidental medical exposures

Confirm if you investigate any/all the case when:

41
(a) a treatment with unsealed radioactive radiation sources has been administrated either to
another patient or to another tissue (other radiopharmaceutical), or using activities
significantly higher than those prescribed by the nuclear medicine physician;
(b) the activity administrated for diagnosis purposes has been significantly higher than those
prescribed by the nuclear medicine physician;
(c) the activities used for diagnosis procedures have been repeatedly higher than those set out
by the reference levels;
(d) occurrence of flaws or malfunctions of the equipments, accidents or other unusual events
that may lead to exposures of the patient significantly different from the intended ones.

Confirm if in the above-mentioned case:

(a) you calculate or estimate the received doses and their distribution into the patient’s body;
(b) you indicate the corrective actions necessary to prevent the reoccurrence of such an
incident;
(c) you implement all the corrective actions;
(d) you submit to CNCAN and to the Ministry of Health, as soon as possible after the
investigation, a written report on the incident cause, including the information specified at
points (a) – (c);
(e) you inform the patient and his physician on the incident.

42
 Annex no. 3

Checklist for radiological safety assessment in view of identifying and preparing the
main aspects aimed during the CNCAN’s control

I. IDENTIFYING INFORMATIONS
Name of the institution:
Social headquarters
Address of radiological facility:
Telephone/facsimile/e-mail:
Authorization number
I-6. Name and qualification of the radiation safety responsible:
Name:
Degree:
Level 2 Practise Permit, , issued by CNCAN:
Experience:
I-7. Name and qualifications of radiation protection qualified expert:
Name:
Degree:
Level 3 Practise Permit, , issued by CNCAN:
Experience:
I-8.
Name and qualification of medical physicist:
Name:
Degree:
Level 2 Practise Permit, , issued by CNCAN:
Experience:
I-9.
Name and qualification of nuclear medicine physician
Name:
Degree:
Level 2 Practise Permit, , issued by CNCAN:
Experience:

II. CHECKING UP OF THE RADIATION SAFETY

II – 1. Description of the used radioactive materials

Radionuclide/ Maximum handled activity Physical/chemical
radiopharmaceutical (Bq) form

II – 2. Description of the measuring and handling equipments.

Equipment type Producer Model no. Number Observations
Dose calibrator
Imagistics
equipment

43
 Syringe shield
Tong
Forceps
Lead blocks
99m
Tc generator
Chimney hood
Xenon trap
Detector

II – 3. Arrangements description

Describe any difference or modification from the arrangements approved by CNCAN

and/or considered in the safety assessment (for example: shielding design, building
materials, etc.):
a) Was the radiological safety assessment performed by a qualified Yes No
expert prior to any modification?
b) Are the thickness and type of shielding appropriate for the types and Yes No
intensity of the radiation produced by X-ray devices?

II – 4. Description of the radiological safety control equipment

a) Is there a proper number of lead containers, fixed or Provided Yes No
portable shields for the shielding in the handling or storage ?
room? Used? Yes No
b) Is there an equipment fro handling ionizing radiations Provided Yes No
sources at distance (tongs, forceps, etc.) available? ?
Used? Yes No
c) Are the chimney hoods properly ventilated for the Provided Yes No
cases when high doses of 131I are handled and when the ?
Tc-99m source is taken out? Used? Yes No
d) Is there a sewerage lab system (decant, sinks, toilets, etc.) connected Yes No
directly to the radioactive sewerage system?
e) Are there provisions for radioactive waste storage prior Yes No
to evacuation ?
f) Is there a compartment in the sources storage place for solid Yes No
radioactive waste disposal/storage?

II – 5. Warning signs
Posters Provided? Yes No
Legible? Yes No
In Yes No
Romanian?

II – 6. Management implication in ensuring radiation safety

a) Does the management know the authorization conditions and limits? Yes No
b) Does the management ensure sufficient qualified personnel? Yes No
c) Does the management ensure the authority of the person responsible for Yes No
radiation safety to stop the unsafe operation
d) Does the management ensure proper resources for personnel training Yes No
(time, money, national and international courses)

44
 e) Does the management ensure proper protection equipment? Yes No
Are the digital individual dosimeters available? Yes No
Are the individual photo dosimeters available? Yes No
f) Does the management ensure periodical examinations Written Yes No
of the program (internal audit) and recommendations? examinations? Yes No
Fulfilled?
i) Last date of program reexamination:_____________________________
ii) Recommendations:

II – 7. Measures on radiation safety

a) Does the person responsible for radiation safety (RRS) possess proper Yes No
knowledge and a corresponding level 2 practice permit issued by CNCAN?
b) Does the RRS have at his disposal radiation protection experts and medical Yes No
physicists?
c) Does the RRS know CNCAN regulation requirements and the authorization Yes No
conditions?
d) Has the RRS time and sufficient resources for fulfilling the tasks (for Yes No
example: he has no other responsibilities, possesses the technical means and is
helped with the secretarial work)?
e) Does the RRS ensure that the workers possess corresponding knowledge Yes No
necessary for the activities using radioactive sources?
f) Does the RRS manage the initial and periodical training of the workers? Yes No
g) Does the RRS keep proper records to prove that the workers and population Yes No
radiation protection requirements are fulfilled?
h) Are there provisions on sources management (inventory, use procedures Yes No
and receiving/delivery as radioactive waste record, radioactive
sources consumption register, radioactive sources evidence Implemented Yes No
register, radioactive waste evidence register)?
i) Are there provisions on the radiological safety program Procedures Yes No
review and audit? implemented Yes No

II – 8. Radiological safety assessment and quality assurance

a) Did radiological incidents or accidents take place/occur? Yes No

b) If they did, were accidents/incidents investigation reports prepared? Yes No
c) Were the safety assessments reviewed, were these
reviews carried out based on the lessons learnt from the Yes No
incidents or accedents reported to other similar faciliites?
d) Is there a written qualitz assurance program? Procedured? Yes No
Implemente Yes No
d
e) Are the maintenance and repair works Programmed Yes No
(measurement equipment, imagistic facilities, No
ventilation systems) carried out in conformity with the Fulfilled Yes
producers’ recommendations?

45
 f) Are the repair/maintenance procedures: Drawn up? Yes No
Applied? Yes No

III. WORKERS PROTECTION CONTROL

III – 1. Classification of areas

a) Are the controlled areas demarcated? Yes No
b) Are the authorized signalings in the controlled area access ensured? Yes No
points: legible? Yes No
in Romanian? Yes No
c) Is the radioactive sources (including waste) storehouse located in proper Yes No
physical conditions?
i) Is it locked/ensured with keys under controlled access? Yes No
ii) Is the sign “danger of radiations” ensured? Yes No
legible?
vi) Is there proper shielding (individual containers, shielded rooms)? Yes No
vii) Is it reserved for radioactive sources only? Yes No
d) Are the monitored areas demarcated? Yes No
e) Are the warning inscriptions and signs at the necessary? Yes No
entrance in the monitored areas: ensured? Yes No
legible? Yes No
in Romanian? Yes No

III. 2. Working rules and surveillance

a) Are written working rules in radiotherapy se out in Romanian (specific Yes No
procedures)?
b) Do the rules include investigation levels, authorized levels and the procedures Yes No
to be observed when a level is exceeded?
c) Are the workers trained on the procedure implementation? Yes No
d) Is a proper surveillance of the radiotherapy workers carried out in order to Yes No
ensure the protection measures, procedures and rules and the safety provisions
are observed?
e) Specific working procedures for:
i) the assistants taking care of the sick: Provided? Yes No
Adequate? Yes No
Applied? Yes No
ii) diagnosis examinations: Provided? Yes No
Adequate? Yes No
Applied? Yes No
iii) therapeutic administrations: Provided? Yes No
Adequate? Yes No
Applied? Yes No
iv) safety systems repair and maintenance: Provided? Yes No
Adequate? Yes No
Applied? Yes No
v) carrying out/performing the contamination monitor and Provided? Yes No
dosimeter measurements: Adequate? Yes No
Applied? Yes No

46
III - 3. Individual monitoring
a) Is there an authorized body to ensure the personnel dosimetry? Yes No
b) Are there dosimeters (photodosimeters, TLD, digital dosimeters etc. )? Yes No
Type: …………………………………….. No.: ……………………….
i) Are they proper? Yes No
ii) Calibrated and/or checked up? Yes No
iii) Read with the required frequency? Yes No
c) Are the personnel exposures within the authorized limits? Yes No
d) Are the available area and portable surveillance instruments:
Type: ………………………………. No.:……………………………….
i) proper? Yes No
ii) calibrated? Yes No
iii) operational? Yes No
iv) Is the operation checking up carried out prior to their use? Yes No
e) Does the surveillance carried out by an authorized body prove that the shields Yes No
are proper and that the dose rates around the working area do not exceed the
authorized radiation levels?
f) Are tests regularly carried out by the authorized bodies on the leaktight of the Yes No
used sealed radioactive sources?
g) Are the contamination measurement instruments: Yes No
i) proper? Yes No
ii) calibrated? Yes No
iii) operational? Yes No

IV. VERIFICATION OF PUBLIC RADIATION PROTECTION

IV-1. Control of visitors

a) Is the access of visitors permitted to the controlled Yes No
area?
b) Are the visitors entering the controlled area provided with Yes No
adequate information ?
c) Is the access to the controlled areas adequately controlled? Yes No

IV-2. Sources of exposure

a) Are the shielding and other protective measures optimised for Yes No
restricting public persons exposure to ionizing radiation
sources?
b) Are proper warning equipments mounted in the Yes No
controlled/monitored areas adjacent to the unsurveyed areas ?
c) Is the individual population – visitors monitoring by means of Yes No
dosimeters ensured? (photodosimeters, digital dosimeters, etc.)

IV. 3. Radioactive waste and their disposal

a) Are there provisions on sources and/or radioactive waste delivery to Yes No
STDR or other authorized bodies when they are no longer used or finished?
b) If the sources are no longer used and they are disposed of, does the Yes No
authorization holder have a proper plan of transfer or source disposal as
radioactive waste?

47
 c) Are measures for the control of radioactive waste disposal/release into the Yes No
environment under the contamination prevention conditions provided?

IV-4. Monitoring of public persons exposure

a) Are routine periodical measurements of the exposure rates in the Yes No
public areas adjacent to the controlled and monitored ares carried
out by the staff, properly trained, using the own equipments or
by an external qualified body?
b) Do the measurements results show that shielding is adequate and Yes No
that dose rates outside the controlled and supervised areas are in
accordance with the authorised radiation levels?

V. EMERGENCY INTERVENTION TRAINING

V. 1. Emergency plan
a) Is there any written plan? Yes No
b) Is the plan periodically reviewed and updated? Yes No
c) Does the plan take into consideration the experience gained from the accidents Yes No
occurred in similar circumstances?
d) Does the plan include radioactive sources and materials recovery procedures Yes No
that cannot be recovered otherwise?
e) Is the radiological emergency intervention equipment ensured? Yes No

V. 2. Training and exercises

a) Are the workers involved in the training plan implementation? Yes No
Yes No
b) Are there provisions in the plan on repetitions (exercises) at proper time Yes No
intervals in collaboration with emergency intervention organizations set out by
the authority in conformity with the law?
c) Date of the last exercise:

VI MEDICAL EXPOSURE

VI- Responsibilities
1.
a) No patient is subjected to radiations exposure unless exposure Yes No
is prescribed by a practitioner physician? Yes No
b) Is there a sufficient number of medical personnel, properly Yes No
prepared for carrying out their assigned responsibilities (tasks)?
c) Are the quality assurance and the imagistic diagnosis Yes No
requirements fulfilled with the advice of a radiological physics
expert?
VI-2. Justification
a) Are diagnostic and interventional medical exposures justified by Yes No
taking into account the benefits and risks of alternate techniques
that do not involve medical exposure?

48
 b) Are there any procedures ensuring that exposure of humans for Yes No
medical research is in accordance with the Helsinki Declaration
and follows the guidelines of application prepared by the Council
for International Organizations of Medical Sciences and the
World Health Organization, the regulations of the Ministry of
Health (MS) respectively?
c) Is each case of human exposure for medical research approved Yes No
by the Ministry of Health?
d) Are there and are the standardized procedures for specific mass Yes No
screening examinations or for operational, legal and health
assurance purposes?

VI – 3. Practice optimization

a) Does the practitioner physician ensure that the appropriate Yes No

radiological installation is used, that the exposure of the patient is
the necessary one in order to achieve the diagnostic objective, and
take into account the relevant information from the previous
examinations so as to avoid unnecessary additional exposure?
b) Does the practitioner physician, the technologists or other imaging Yes No
staff select the parameters so that their combination leads to a
minimum exposure of the patient with an acceptable image quality
by:
i) proper selection of the radiopharmaceutical and its activity that is
correlated with the special requirements for children or for
patients with organic diseases;
ii)using the accumulation blocking methods into the organs that are
not under the study and excreta acceleration;
iii) images processing and acquisition under proper conditions.
c) Are the radiological examinations specific to the nuclear medicine, Yes No
in case of pregnant women or that might be pregnant carried out
under well justified clinical conditions?
d) For the breast feeding women, is the breast feeding cessation during Yes No
the milk secretion time period, with a radiopharmaceuticals
concentration level that may affect the breast fed children,
recommended?
e) Is the radiopharmaceutical administration for children diagnosis Yes No
carried out only under well justified clinical conditions, is their
activity and quantity reduced function of the weight and body
surface or in conformity with other proper criteria?
VI – 4. Dosemeter Calibration
a) Is the calibration of the dosemeter used for medical exposure Yes No
traceable to a standard dosimetry laboratory?

49
 b) Are the unsealed sources calibrations carried out function of the Yes No
activities determinated and registered at the radiopharmaceuticals
administration date?
VI. 5. Clinic dosimetry
Are the representative absorbed doses procedural determinated and Yes No
recorded?
VI – 6. Quality assurance
Does the medical quality assurance program include:
a) measurements and verification of physical parameters Drawn up? Yes No
for the gamma rooms and for the other nuclear In Yes No
medicine equipments used in the lab are carried out at application?
the time of commissioning and periodically thereafter
by the authorized personnel?
b) are there any written records of the relevant procedures and results? Yes No
c) the checking up, calibration and the dosimetric Drawn up? Yes No
equipment operation and contamination monitoring In Yes No
conditions are: application?
d) verification of the patient identity? Yes No
Yes No
e) Are independent and regular (audits) reviews of the quality Yes No
management documents and system carried out?
VI. 7. Dose constraints
a) Does the Ministry of Health specify dose constraints applicable for the Yes No
protection optimization of the radiation-exposed persons for medical research
reasons if these medical exposures do not bring any direct benefits to the Not
exposed persons? carried out
b) Have dose constraints been set out for the persons consciously exposed Yes No
when voluntarily helping the patients under medical treatment?
c) Is the individual monitoring of these persons ensured? Yes No
VI. 8. Accidental medical exposures investigations
a) Has the authorization holder, by the medical or technical personnel, immediately
investigated any of or all situation when:
i) A diagnosis dose was higher than the intended one or the doses have been Yes No
repeatedly exceeded over the approved limits?
ii) an equipment failure, accident, error or any other unusual event provoked Yes No
the patient significant exposure to the intended one?
b) For every investigated incident, the authorization holder, by the medical or technical
personnel:
i) has calculated or assessed the received doses and their distribution in the Yes No
patient?
ii) has indicated corrective measures to prevent the reoccurrence of such an Yes No
incident?
iii) has implemented all the corrective measures under his control? Yes No
iv) has submitted to CNCAN, as soon as possible, a written report on the Yes No
accident causes, including all information specified at points i) ÷ iii)?
v) has informed the patient and his physician on the incident? Yes No

VII – AVAILABLE RECORDS

50
a) Copy of the authorization.
b) Records management system.
c) Individual dosimetry, present and past.
d) Area dosimetric surveillance (dosimetric and contamination monitor measurements).
e) Instruments tests and calibrations.
f) Leaktight tests of the sealed radioactive sources.
g) Sources inventory and their movement evidence (sources management).
h) Safety and radiation protection program analyses and audits.
i) Radiological accidents and incidents investigation reports.
j) Installing-mounting, service, maintenance and periodical checking up of the radiotherapy equipments.
k) Radiotherapy lab endowment modifications.
l) Initial and continuous personnel training assurance.
m) Occupational exposed persons medical surveillance.
n) Radioactive waste disposals.
o) Sources and radioactive materials transport:
i) accompanying documentation;
ii) packages dosimetric measurements;
iii) shipment details/data.
p) Monitoring of the radioactive excreta elimination arisen from the patients treated with unsealed
radioactive sources.
q) Clinical dosimetry records.

ANNEX No. 4

Table No. 1: List of the minimum checking ups for the equipments used in the nuclear medicine

Instrument Periodical or acceptance/reference Daily checking ups

checking ups
Dose calibrator Precision, Accuracy, Linearity, Geometry, Reproducibility, background
Fund
Counters Operation.../timer, calibration in energy, Calibration in energy,
energetic resolution, sensibility, counter background
precision, linearity at energy, fund,
linearity at activity, geomerty
Gamma room (including Setting of the PHA window, energetic Settings of the PHA window,
SPECT) resolution, linearity in the energetic uniformity, sensibility,
response, intrinsic uniformity, system background, rotation center,
uniformity, intrinsic linearity, intrinsic collimator
spatial resolution, spatial resolution of the
system, counter performance, sensibility,
whole body uniformity, whole body
resolution, head shielding leakage, pixel
size, computer timing, rotation center,
tomographic uniformity, tomographic
spatial resolution, total SPECT
performance
Films processor Veil level, speed, sensibility Veil level
PET Calibration checking up, uniformity, Calibration checking up,
spatial resolution, scatter fraction, normalization, blank scan,
sensibility, count rate loses, saner cross scanner cross calibration
calibration, drifts in coincidence timing,
drift in energy threshold, mechanical
movement of the detectors rings,
removable septa positioning, lasers
alignment, attenuation correction
accuracy, dead time correction accuracy,
scatter correction accuracy, random
coincidence correction accuracy

51
 Table no.2: Dose rates recommended for classification of the areas

Dose rate Value for the Value for the Value for the
controlled monitored area unsurveyed area
area
Instantaneous, mediated per 1 minute (IDR) >2000μSv/h >7,5 μSv/h <7,5 μSv/h
Mediated per 8 hours, taking into >7,5 μSv/h >0,5 μSv/h <0,5 μSv/h
consideration the use and the load for the
most unpropitious case (TDR)
Mediated per 2000 hours, taking into >3 μSv/h >0,15 μSv/h <0,15 μSv/h
consideration the use and the load for the
most unpropitious case (TADR)

Table no. 3: Recommendations on breast feeding cessation time periods in order

to ensure a child dose 1 mSV

Radiopharmaceutic Activity Instructions/Specifications

(1) (2) (3)
51
Cr-EDTA * The breast feeding cessation is not usually necessary
99m
Tc DISIDA * The breast feeding cessation is not usually necessary
99m
Tc DMSA * The breast feeding cessation is not usually necessary
99m
Tc DTPA * The breast feeding cessation is not usually necessary
99m
Tc diphosphonate * The breast feeding cessation is not usually necessary
99m
Tc glucoheptonate * The breast feeding cessation is not usually necessary
99m
Tc gluconate * The breast feeding cessation is not usually necessary
99m
Tc HMPAO * The breast feeding cessation is not usually necessary
99m
Tc MIBI * The breast feeding cessation is not usually necessary
99m
Tc colloid sulphide * The breast feeding cessation is not usually necessary
111
In leucocytes 20 MBq The breast feeding cessation is necessary if the
activity is higher than that specified in column 2
201
Tl chloride 80 MBq The breast feeding cessation is necessary if the
activity is higher than that specified in column 2
99m
Tc MAG3 100 MBq The breast feeding cessation is necessary if the
activity is higher than that specified in column 2
99m
Tc MAA 100 MBq The breast feeding cessation is necessary for 13 hours
99m
Tc pertechnetate 800 MBq The breast feeding cessation is necessary for 48 hours
99m
Tc pertechnetate 80 MBq The breast feeding cessation is necessary for 24 hours
99m
Tc erythrocyte The breast feeding is ceased function of the activity
concentration in the milk
99m
Tc aerosol The breast feeding is ceased function of the activity
concentration in the milk
99m
Tc MAG3 >100MBq The breast feeding is ceased function of the activity
concentration in the milk
99m
Tc microsphere The breast feeding is ceased function of the activity
concentration in the milk
99m
Tc pirophosphonated The breast feeding is ceased function of the activity
concentration in the milk
123
I iodid The breast feeding is ceased function of the activity
concentration in the milk
123
I MIBG The breast feeding is ceased function of the activity
concentration in the milk
123
I hipurane The breast feeding is ceased function of the activity

52
 concentration in the milk
32
P sodium phosphonate Brest feeding cessation
67
Ga citrate Brest feeding cessation
123
I HSA Brest feeding cessation
131
I iodide Brest feeding cessation

 If the activity is not specified, its value is higher than the currently used one for the respective
investigations .
 123I shall not contain 124I and 125I.

Table no. 4: Recommendations on the pregnancy avoidance time periods in order to ensure a fetus/embryo
dose under 1 mSv

Radiopharmaceuticals Treatment for All the activities Time period for avoiding
(1) (2) necessary for the the pregnancy (month)
treatment up to the
activity of (MBq)
131
I iodite* thyrotoxicosis 800 4
131
I iodite* Thyroid cancer 5000 4
131
I MIBG* Phaeochromocytoma 5000 4
32
P phosphate Polycythemia 200 3
89
Sr chloride Bones metastases 150 24
90
Y colloid Arthritis 400 0
90
Y colloid Malignant tumors 4000 1
169
Er colloid Arthritis 400 0

*Table
The calculations
no. 6: ALI are based on the
fordoses received
used by the fetus/embryo
Table pursuant
no. 7: to the external
CMA values for exposure, butused
the most for
min values131 the most
these treatments the transfer of I into the patient shall be also taken into consideration.
radionuclides in the nuclear medicine
Note:radionuclides in the nuclear
Because the relation betweenmedicine
the activity and the dose received by the fetus/embryo is not linear, for
treatments exceeding the values specified in the table, a medical Radionuclide physicist shall CMA be consulted
(Bq/m3) in view of
Radionuclide
estimating ALI min
the fetus/embryo (Bq
dose. 3 . 3
H 3 10
) 14
C 1.102
3 Table no. 5: Time. periods
H 1 109 recommended for following the instructions
18 after the. treatment
2 with 131I
14
F 5 10
C 3.107 32
P 3.101
Effective
18
F dose rate at2.10
1m8 Estimated residual activity of Time51periods recommended for following the
(MBq) 2.103the treatment
Crinstructions after
from
32
P the patient (Sv/h)
.
6 10 6
57 . 1
Co 9 10
51
Cr < 40 5.108 <800 60 3 weeks
Co 3.100
57
Co < 20 .
2 10 7 <400 67 2 weeks
Ga 3.102
60
Co <10 .
7 10 5 <200 68 1 week
Ga 1.103
67
Ga <5 .
7 10 7 <100 89 4 days
Sr 1.101
68
Ga <3 .
2 10 8 <60 90 24 hours
89 . 6
Y 5.101
Sr 3 10 99
Mo 8.101
90
Y 7.106 99m
Tc 3.103
99
Mo 2.107 111
In 3.102
99m
Tc 7.108 123
I 4.102
111
In 7.107 124
I 7.100
123
I 1.108 125
I 6.100
124
I 2.106 131
I 4.100
125
I 1.106 137
Cs 1.101
131
I 9.105 153
Sm 1.102
137
Cs 2.106 186
Re 7.101 53
153
Sm .
3 10 7 201
Tl .
1 10 3
186
Re 1.107
201
Tl 2.108
 ANEXA 5
REFERENCE DOCUMENTS RECOMMENDED IN NUCLEAR MEDICINE PRACTICE DEPLOYMENT

1. EUROPEAN COMMISSION, Council Directive 96/26 EURATOM of 13 May 1996 laying dawn basic safety
standards for the protection of the ehalth of workers and general public against the danger arising from
ionizing radiation, Official Journal of the European Communities, Luxembourg,1996.
2. EUROPEAN COMMISSION, Council Directive 97/43 EURATOM of 30 June 1997 on health protection of
individuals against the danger of ionizing radiation in relation to medical exposure, Official Journal of the
European Communities No. L180/22-27, Luxembourg, 1997.
3. EUROPEAN COMMISSION, Radiation protection following iodine-131 therapy (Exposure due to outpatients
or discharged inpatients). Radiation Protection 97, EC, Brussels, 1998.
4. EUROPEAN COMMISSION, Guidance for protection of unborn children and infants irradiated due to
parental medical exposure. Radiation Protection 100, EC, Brussels, 1998.
5. EUROPEAN COMMISSION, Guidance on medical exposures in medical and biomedical research. Radiation
Protection 99, EC, Brussels, 1998.
6. EUROPEAN COMMISSION, Guidance on diagnostic referece levels DRLs for medical exposures. Radiation
Protection 109, EC, Brussels, 1999.
7. EUROPEAN COMMISSION, Criteria for acceptability of radiological (including radiotherapy) and nuclear
medicine installations. Radiation Protection 91, EC, Brussels, 1998.
8. INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards, 1996, Vienna
9. INTERNATIONAL ATOMIC ENERGY AGENCY, Assessment of Occupational Exposure due to Internal
Sources of Radiation. Safety Standards Series, Safety Guide No. RS-G-1.3, IAEA, Vienna, 1999.
10. INTERNATIONAL ATOMIC ENERGY AGENCY, Assessment of Occupational Exposure due to External
Sources of Radiation. Safety Standards Series, Safety Guide No. RS-G-1.3, IAEA, Vienna 1999.
11. INTERNATIONAL ATOMIC ENERGY AGENCY, Radiological Protection for medical exposure to
ionizing radiation, Safety Standards Series, Safety Guide No. RS-G-1.5, IAEA, Vienna , 2002.
12. INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Control of Nuclear Medicine Instruments,
IAEA-TECDOC-602, Vienna, 1991.
13. INTERNATIONAL ATOMIC ENERGY AGENCY, Quality control atlas for scintillation camera systems,
Viena 2003.
14. INTERNATIONAL ATOMIC ENERGY AGENCY, Management of small quantities of radioactive waste,
IAEA-TECDOC-1041, Vienna, 1998
15. INTERNATIONAL ATOMIC ENERGY AGENCY, Principles for exemption of radiation sources and
practices from regulatory control, Safety series no. 89, Vienna, 1988
16. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 52,
Protection of the patients in nuclear medicine, Pergamonn Press, Oxford and New York, 1987
17. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 53,
Radiation dose to patients from radiopharmaceuticals, Pergamonn Press, Oxford and New York, 1988
18. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 60,
Recommendations of the International Commission on Radiological Protection, Pergamonn Press, Oxford
and New York, 1991

54
19. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 62,
Radiological Protection in Biomedical Research, Pergamonn Press, Oxford and New York, 1993
20. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 68, Doses
Coefficients for Intakes of Radionuclides by Workers, Pergamonn Press, Oxford and New York, 1991
21. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 69, Age
dependent Doses to Member of the Public from Intake of Radionuclides: Part 3 Ingestion Dose Coefficient,
Pergamonn Press, Oxford and New York, 1991
22. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 71, Age
dependent Doses to Members of the Public from Intake of Radionuclides: Part 4 Inhalation Dose
Coefficients, Pergamonn Press, Oxford and New York, 1991
23. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, ICRP Publication 73,
Radiological Protection and Safety in Medicine, Pergamonn Press, Oxford and New York, 1996
24. NATIONAL ELECTRICAL MANUFACTURERS, Publication no. NU1-1980,Performance Measurements
of scintillation cameras, Washington, 1980.
25. NATIONAL ELECTRICAL MANUFACTURERS, Performance Measurements of Positron Emission
Tomographs, Washington.
26. WORLD HEALTH ORGANIZATION, QA of Pharmaceuticals: A Compendium of Guidelines and Related
Materials, Vol 2, Good Manufacturing Practice and Inspection, WHO, Geneva, 1999.
27. EUROPEAN PHARMACOPOEIA, Third Edition, 1997, Council of Europe, Strasbourg, 1996, as amended
by the Supplement 2000, Council of Europe, Strasbourg, 1999.

55