Documente Academic
Documente Profesional
Documente Cultură
to IEc 60601-1
and fully automatic test models Appendix A – IEC 60601-1 Test Limits 14
■ User controllable power up
Appendix B – IEC 60601 Body Model 14
and power down
■ UTS system - optimises times Appendix C – Patient Environment 15
for test routines Appendix D – IEC 60601-1 Collateral Standards 16
The new Rigel 277 plus is a portable medical electrical safety analyser combining IEC/EN 60601-1
compliance with additional test facilities for IEC/EN 61010 (Laboratory Equipment) including Touch
Leakage, Voltage Measurement and dedicated IEC 61010 Measuring Device (Body Model).
For further information call + 44 (0) 191 587 8730, visit www.rigelmedical.com
or email sales@rigelmedical.com
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
2 3
between other persons touching medical equipment classed as medical electrical equipment and is overview of the symbols used in IEC 60601 is provided defined by IEC 60601, however visual inspections
and the patient, both intentional and unintentional (see specified by the manufacturer to be connected by in the standard, table D1. For the purpose of this form a critical part of the general safety inspections
Appendix E). functional connection or use of a multiple portable booklet, a selection of the most commonly used during the functional life of medical equipment. In
socket-outlet. symbols is displayed below: most cases, 70% of all faults are detected during
F-Type Applied Part
visual inspection.
Applied Part which is electrically isolated from Earth Class I
and other parts of the medical equipment i.e. floating Equipment protection against electric shock by Visual inspection is a relatively easy procedure to
F-type Applied Parts are either type BF or type CF (Earthed) additional protection to basic insulation Class I make sure that the medical equipment in use still
Applied Parts. through means of connecting exposed conductive conforms to the specifications as released by the
parts to the protective Earth in the fixed wiring of the manufacturer and has not suffered from any
Type B Applied Part Class II
installation. external damage and/or contamination.
Applied Part complying with specified requirements for
protection against electric shock. Type B Applied Parts Class II These can include the following inspections:
Earth Reference point
are those parts, which are usually Earth referenced. Also referred to as Double Insulated. Equipment
• Housing Enclosure – Look for damage, cracks
Type B are those parts not suitable for direct cardiac protection against electric shock by additional
etc
application. protection to basic insulation through means of i.e. “Conformité Européenne” • Contamination – Look for obstruction of
supplementary insulation are provided, there being no
Type BF Applied Part moving parts, connector pins etc
provision for the connection of exposed metalwork of
F-Type Applied Part complying with a higher degree of Type B Applied Part • Cabling (supply, Applied Parts etc) – Look for
the equipment to a protective conductor and no
protection against electric shock than type B Applied cuts, wrong connections etc
reliance upon precautions to be taken in the fixed
Parts. Type BF Applied Parts are those parts not • Fuse rating – check correct values after
wiring of the installation.
suitable for direct cardiac application. Defibrillation proof type B Applied Part replacement
NOTE: CLASS II EQUIPMENT MAY BE PROVIDED • Markings and Labelling – check the integrity of
Type CF Applied Part
WITH A FUNCTIONAL EARTH TERMINAL OR A safety markings
F-Type Applied Part complying with the highest degree Type BF Applied Part
FUNCTIONAL EARTH CONDUCTOR. • Integrity of mechanical parts – check for any
of protection against electric shock. Type CF Applied
obstructions
Parts are those parts suitable for direct cardiac
1.3. SYMBOLS AND MARKINGS Defibrillation proof type BF Applied Part
application. 2. EARTHBOND TESTING
The IEC 60601 has defined the requirements for
Medical Electrical Equipment Earthbond Testing, also referred to as Groundbond
information / data to be present on the medical
Electrical equipment designed for treatment, Type CF Applied Part Testing, tests the integrity of the low resistance
equipment’s nameplate, in order to form an
monitoring or diagnoses of patients, powered from not connection between the earth conductor and any
unambiguous identification of the equipment.
more than one connection to mains supply and which metal conductive parts, which may become live in
Defibrillation proof type CF Applied Part
are not necessarily in physical or electrical contact with Information must include: Manufacturer’s name, model case of a fault on Class I medical devices.
the patient or transfers energy to or from the patient or number, serial number, electrical requirements etc.
Although many Class I medical devices are
detects such energy transfer to or from the patient. The IEC 60601 standard refers to a large variety of supplied with an Earth reference point, most if not
1.4. VISUAL INSPECTION
Medical Electrical System symbols for use on medical equipment, medical all medical devices require multiple Earthbond tests
Combination of equipment of which at least one is systems, accessories and other related parts. A full The process of visual inspection is not clearly to validate the connections of additional metal
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
4 5
accessible parts on the enclosure. Prolonged use of testing at high currents can lead stringent rules on the design of medical equipment currents. Currents applied under the skin can result
to a high probe temperature. Care should be taken so as to prevent any patient or operator being in far greater consequences. Currents as low as
The test current is applied between the Earth pin of
to avoid touching the probe tip under these exposed to currents not part of the functional 15µA can result in fatality.
the mains supply plug and any accessible metal
conditions. operation of the device. These currents are referred
part (including Earth reference point) via a The limits for leakage currents within the IEC
to as leakage currents.
dedicated Earthbond test lead (clip/probe). 60601-1 requirements are set to minimizing the
3. LEAKAGE MEASUREMENTS
IEC 60601 defines leakage current of three different probability of ventricular fibrillation to a factor as
The IEC 60601-1 (clause 8.6.4) requires a
Research has shown that current not voltage is often sources: low as 0.002 (Limit of 10µA for CF Applied Part
minimum test current of 25A AC or 1.5 times the
the source of injury or death. It takes only a small under normal condition). See Appendix A for a full
highest rated current of the relevant circuit(s), Earth Leakage: current flowing down the
amount of current to cause major consequences. overview of the IEC 60601-1 test limits.
which ever is greater. The open circuit voltage of protective Earth conductor of the mains inlet lead.
the current source should not exceed 6V. When an electrical current flows through the human The following tests find their origin from the IEC
Enclosure Leakage: current flowing to Earth
body the effect is influenced by two main factors. 60601-1 but are specific the AAMI and NFPA 99
A test current of 25A AC is most commonly used. through a person by touching the medical
Firstly the amount of current and secondly the length standards (USA)
Due to the exposure of high current, some (parts of equipment / system or part of.
of time the current flows.
the) equipment could be damaged and thus • Patient Leakage - Applied Part to Ground.
Applied Part or Patient Leakage: current
requires a lower test current. However, the For example, the heart stops if the current persists Similar to Patient Leakage described above.
flowing through a person to Earth from the Applied
Earthbond test is designed to stress the for: • Patient Leakage - Applied Part to Case.
Part or current flowing from a person to Earth via
connection under fault conditions. a) 250mS at 40mA Similar to Patient Leakage except that the
the Applied Part by applying unintended voltage
b) 100mS at 100mA leakage current path is from the Applied Parts,
Faults in the detachable power cord account for from an external source.
c) 50mS at 200mA through the patient, to the case of the
80-90% of all Earthbond failures, as most moulded
Applied Part / Patient Leakage can be classed into EUT/DUT.
power cables are prone to stress when the cables Consider the following examples of the effect of
number of measurements such as: • Patient Auxiliary (Applied Part to Applied Part);
are dropped. current on the human body when applied to the skin
(non invasive); • Patient Leakage (please refer to the Similar to Patient Auxiliary current.
For fixed installations (ie MRI or X-RAY equipment) • Patient Auxiliary (Applied Part to All); Similar to
corresponding paragraph)
a Point-to-Point continuity measurement can be 0.9–1.2mA Current just perceptible
• Patient Auxiliary Leakage (please refer to the Patient Auxiliary current.
made. The resistance is then measured between 15.0–20.0mA Release impossible: cannot be
corresponding paragraph)
two probes, where one would be connected to the tolerated over 15 minutes
• Patient F-type Leakage (please refer to the For the purpose of this booklet, the focus will be on
incoming Earth reference point and one probe 50.0–100.0mA Ventricular fibrillation, respiratory
corresponding paragraph) the directly related leakage measurements as per
placed on metal accessible parts of the medical arrest, leading directly to death
100.0–200.0mA Serious burns and muscular IEC 60601-1.
installation.
contraction of such a degree that Applied Part or Patient Leakage is the most
Test limits are set at 0.1 ohm for fixed power cords
the thoracic muscles constrict the important part of the leakage measurement on any
and 0.2 ohm for equipment with a detachable WARNING - MAINS VOLTAGE APPLIED TO
heart medical device. Applied Parts are directly in APPLIANCE
power cord. See Appendix A for a full overview of
contact with the patient and are in case of invasive It is important to verify that a Medical Device with
the IEC 60601-1 test limits. Compare these values to the fact that 250mA of
devices placed under the patient's skin, which moving parts (e.g. motor or pump) is safely
current is required to power a 25 watt lamp.
forms our natural protection against electrical mounted to allow movement without causing
For this reason, the IEC 60601 committee has set
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
6 7
damage to equipment or personnel. Secondary purpose of this booklet, the only highlighted SFC single fault condition (neutral open circuit). The treatment or care) of the Medical Device.
Earth paths will effect the leakage measurements are the interrupted Earth connection (Open Earth) Earth leakage test is valid for Class I equipment
IEC 60601-1 specifies that the measurements are
and might give false PASS readings. Always make and interruption of any of the supply conductors with Types B, BF and CF applied parts. Appendix
done under normal and reverse operation of the
sure that the device under test is positioned safely (Open Neutral). A shows the pass/fail limits as per IEC 60601-1
mains supply and single fault conditions Open
and isolated from Earth when measuring leakage. requirements.
IEC 60601-1 specifies that all leakage Neutral circuit and Open Earth. The Enclosure
measurements should be carried out using normal Note - SFC 'Open Earth’ cannot be performed as Leakage Test is valid for both Class 1 and II
3.1. IEC 60601-1 BODY MODEL
and single fault conditions. A typical part of the this would result in zero leakage measurements equipment with Types B, BF and CF Applied Parts.
To ensure a traceable simulation of current as if electrical safety testing procedures is to perform under all circumstances. Appendix A shows the pass/fail limits as per IEC
passing through a human body, measurement the test as follows: 60601-1 requirements.
Diagram A shows a schematic interpretation of
circuits have been designed to simulate the
1. Normal Supply Voltage No (SFC) the Earth Leakage measurement including the Note - for Class II equipment, the Single Fault Earth
average typical electrical characteristics of the
relays operating the single fault conditions. Open tests are not required.
human body. These measurement circuits are 2. Normal Supply Voltage Open Neutral
referred to as Body Models or Measuring Device In the case of Class II devices, or fully insulated
3. Normal Supply Voltage Open Earth
(MD in IEC 60601-1). S5 enclosures, this can be encapsulated by using
4. Reversed Supply Voltage No (SFC) aluminium foil of approximately 200 cm2. The
Some standards such as the AAMI / NFPA 99 and AP S5
5. Reversed Supply Voltage Open Neutral
S1 enclosure leakage is measured by connecting the
the IEC 61010 (electrical equipment for
aluminium foil to the leakage tester. AP
measurement, control and laboratory use) specify 6. Reversed Supply Voltage Open Earth MD
S1
different electrical characteristics to that of the IEC Diagram B shows a schematic interpretation of
MD
60601-1. Diagram A - TestCircuit for Earth Leakage the Earth Leakage measurement including the
In addition to these tests, some manufacturers relays operating the single fault conditions.
The IEC 60601-1 body model or measuring device S5
Earth Leakage, normal conditions - This test
might choose to include voltage on the signal input
is shown in Appendix B. measures the Earth Leakage current under normal S5
/ output terminals (i.e. communication ports such S1 AP
conditions. The current is measured through the
3.2. SINGLE FAULT CONDITION as USB or RS 232). As this test can be destructive,
Measuring Device S8with S1 closed and S5 normal S1 AP
it is not commonly used other than during type
To maintain a Medical Device’s high level of and then S5 reversed. S8
testing of the medical electrical equipment. MD
protection during its operational life, a number of Earth Leakage, single fault, supply open - S5
design features are taken into account to maintain This test measures the Earth Leakage current with MD
3.3. EARTH LEAKAGE TEST
the integrity of the Device's electrical safety. This is a single fault condition (supply open). The current is S1 AP
S5
done by introducing conditions that could occur The Earth Leakage Test shows the current flowing measured through the Measuring Device with S1 Diagram B - Test Circuit for Enclosere Leakage
S8
under normal use (i.e. reversed mains supply or through or via the insulation of the Medical Device open and S5 normal and then S5 reversed. S5
AP Enclosure Leakage, normal condition - This
S1
voltage on signal input/output terminals - SIP/SOP) into the protective Earth conductor. The Earth
test measures the enclosure leakage
R current under
MD
and conditions that can occur under a single fault leakage test is important as it demonstrates the S8
3.4. ENCLOSURE LEAKAGE TEST AP
normal conditions.
S1
The current is measured
condition (SFC). total leakage from the EUT / DUT.
In general, Enclosure Leakage displays the current through the Measuring
S8 Device with S1 and S8
MD
IEC 60601-1 specifies a number of single fault IEC 60601-1 specifies that the measurements are that would flow if a person came into contact with closed and S5 normal and reversed.
conditions (SFC) under its clause 8.1. For the done under normal and reverse operation and the housing (or any accessible part not intended for MD
S5
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
8 S5 9
S1 AP
S5
S1 AP
mains supply and single fault conditions Open Neutral measured through the S1
Measuring Device with S1 AP
open, S8 closed and S5 normal and then S5 reversed. Diagram D shows a schematic interpretation of Diagram E shows a schematic interpretation of the
circuit and Open Earth. The Patient Leakage Test is S8 MD
the F-Type Leakage measurement including the Patient Auxiliary Leakage measurement including
valid for both Class I and II equipment with Types Patient Leakage, single fault, Earth open -This
relays operating the single fault conditions. the relays operating the single fault conditions.
B, BF and CF applied. test measures the Patient Leakage
MD Current with a
S5
Appendix A shows the pass/fail limits as per IEC single fault condition (Earth open). The current is S5
S5
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
10 11
S1 AP
measures the patient auxiliary current under normal Overall, the area of risk assessment and the which will effect the accuracy of low leakage
conditions. The current is measured through the creation of risk management files has become a measurements)
Measuring Device with S1 and S8 closed, S5 growing feature of routine safety testing decisions, • Traceability of measurement results (Do you
normal and then S5 reversed. with different organisations and departments require data storage?)
drawing-up individual plans to deal with specific • Test convenience (test duration, user interface,
Patient Auxiliary, single fault, supply open -
safety hazards. can you save time?) and reduce risk of
This test measures the patient auxiliary current
misinterpretation.
under a single fault condition (supply open). The For the future, therefore, determining the
current is measured through the Measuring Device appropriate levels of electrical testing to be taken
with S1 open, S8 closed and S5 normal and then without compromising the safety of staff or patients Rigel Medical offers a range of test equipment
S5 reversed. will be central to the introduction of cost effective in line with the IEC 60601 and IEC 62353
yet reliable preventative maintenance campaigns. requirements.
Patient Auxiliary, single fault, Earth open -
This test measures the patient auxiliary current Please visit our website www.rigelmedical.com
5. CONCLUSION
under a single fault condition (Earth open). The for a full overview of our product offering or
current is measured through the Measuring Device Electrical safety testing of Medical Electronic register online for our free newsletter on future
with S1 closed, S8 open and S5 normal and then Devices remains a crucial part of the overall safety product releases and product innovations.
S5 reversed. validation of Medical Devices and requires
For further questions or comments relating to
specialised test equipment.
this booklet or on the Rigel Medical product
4. RECORD KEEPING
When choosing your electrical safety analyser offering, please contact John Backes at
Currently, manual paper-based systems provide make sure, firstly, that it can be used to test in johnb@rigelmedical.com
the main method of recording safety testing results accordance with the IEC 60601-1 requirements,
in most hospitals. However, as asset management and secondly that your analyser will enable you to
systems gain more favour as a means of tracking accurately and repeatedly produce the results you
equipment, PC-based test records are likely to require.
become more popular in the future. Such systems
Essential requirements for electrical safety
will enable historical database records to be
analysers are:
established to assist in the formulation of
preventative maintenance programmes and also • User safety (never compromise) 25A AC
contribute to risk assessment calculations. Earthbond (Groundbond) testing up to loads
exceeding 0.2 Ohm
Test instrument manufacturers, who have already
• Measuring device meets the frequency
responded with the introduction of instruments
response of the IEC 60601-1 body model
capable of storing test results for subsequent
• High accuracy and repeatability of leakage
downloading to printers, are therefore likely to
measurement readings (Some manufacturers
develop new testers with PC compatible software
might specify accuracy of full scale reading
programmes for records keeping purposes.
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
12 13
APPENDIX A - IEC 60601-1 TEST LIMITS \ SAFETY AND ESSENTIAL PERFORMANCE -
APPENDIX C: IEC 60601-1 COLLATERAL STANDARDS
COLLATERAL STANDARD: REQUIREMENTS
Earthbond test limit at 25A, 50Hz (© IEC Geneva, Switzerland) FOR THE DEVELOPMENT OF PHYSIOLOGIC
CLOSED-LOOP CONTROLLERS
IEC 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT – PART
Excluding power cord < 0.1 Ω 1: GENERAL REQUIREMENTS FOR SAFETY 1: IEC 60601-1-11 (ANW) MEDICAL ELECTRICAL EQUIPMENT - PART
COLLATERAL STANDARD: SAFETY 1-11: GENERAL REQUIREMENTS FOR BASIC
Including power cord < 0.2 Ω
REQUIREMENTS FOR MEDICAL ELECTRICAL SAFETY AND ESSENTIAL PERFORMANCE -
Type B Type BF Type CF SYSTEMS COLLATERAL STANDARD: REQUIREMENTS
Applied Parts Applied Parts Applied Parts
FOR MEDICAL ELECTRICAL EQUIPMENT AND
Leakage Current Type NC SFC NC SFC NC SFC IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT – PART MEDICAL ELECTRICAL SYSTEM USED IN
Earth Leakage (General) 0.5mA 1mA 0.5mA 1mA 0.5mA 1mA 1: GENERAL REQUIREMENTS FOR SAFETY 2. HOME CARE APPLICATIONS
Enclosure Leakage 0.1mA 0.5mA 0.1mA 0.5mA 0.1mA 0.5mA COLLATERAL STANDARD:
Patient Leakage (dc) 0.01mA 0.05mA 0.01mA 0.05mA 0.01mA 0.05mA ELECTROMAGNETIC COMPATIBILITY
APPENDIX D: IEC 60601-2 PARTICULAR STANDARDS
Patient Leakage (ac) 0.1mA 0.5mA 0.1mA 0.5mA 0.01mA 0.05mA –REQUIREMENTS AND TESTS
(© IEC Geneva, Switzerland)
Patient Leakage (F-Type) NA NA NA 5mA NA 0.05mA IEC 60601-1-3 MEDICAL ELECTRICAL EQUIPMENT – PART
Patient Leakage (Mains on SIP/SOP) NA 5mA NA NA NA NA 1: GENERAL REQUIREMENTS FOR SAFETY – IEC 60601-2-1 MEDICAL ELECTRICAL EQUIPMENT – PART
Patient Auxiliary Current (dc) 0.01mA 0.05mA 0.01mA 0.05mA 0.01mA 0.05mA COLLATERAL STANDARD: GENERAL 2-1: PARTICULAR REQUIREMENTS FOR THE
Patient Auxiliary Current (ac) 0.1mA 0.5mA 0.1mA 0.5mA 0.01mA 0.05mA REQUIREMENTS FOR RADIATION SAFETY OF ELECTRON ACCELERATORS IN
PROTECTION IN DIAGNOSTIC X-RAY THE RANGE 1 MEV TO 50 MEV
EQUIPMENT
IEC 60601-2-2 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT: PART 1- 2-2: PARTICULAR REQUIREMENTS FOR THE
APPENDIX B - IEC 60601 BODY MODEL 4: GENERAL REQUIREMENTS FOR SAFETY OF HIGH FREQUENCY SURGICAL
COLLATERAL STANDARD: PROGRAMMABLE EQUIPMENT
+20 ELECTRICAL
+20 MEDICAL SYSTEMS
IEC 60601-2-3 MEDICAL ELECTRICAL EQUIPMENT PART 2:
Z(ƒ-10)
Z(ƒ-10)
IEC 60601-1-6 MEDICAL ELECTRICAL EQUIPMENT - PART PARTICULAR REQUIREMENTS FOR THE
Z(ƒ)
Z(ƒ)
0 1-6:0GENERAL REQUIREMENTS FOR BASIC SAFETY OF SHORT-WAVE THERAPY
R1
Relative magnitudec) (db): 20 log
R1
-60
COLLATERAL STANDARD: GENERAL
-60 IEC 60601-2-5 MEDICAL ELECTRICAL EQUIPMENT – PART
R1 = 10k Ω ±5%a) R1 = 10k Ω ±5%a)
REQUIREMENTS, TESTS AND GUIDANCE FOR
2-5: PARTICULAR REQUIREMENTS FOR THE
R2 = 1k Ω ±5%a) R2 = 1k Ω ±5%a) ALARM SYSTEMS IN MEDICAL ELECTRICAL
C1 = 0.015 µF ±5% C1 = 50.015 µF6 ±5%
SAFETY OF ULTRASONIC PHYSIOTHERAPY
10 102 103 104 10 10 EQUIPMENT
10
AND
102
MEDICAL
103
ELECTRICAL
104 105 106 EQUIPMENT
Frequency (ƒ) in Hz SYSTEMS Frequency (ƒ) in Hz
a) Measuring Device b) Frequency Characteristics IEC 60601-1-9 (CDIS) MEDICAL ELECTRICAL EQUIPMENT - PART
IEC 60601-2-6 MEDICAL ELECTRICAL EQUIPMENT – PART
2: PARTICULAR REQUIREMENTS FOR THE
Note: The network
MD and voltage measuring instrument above is replaced by the symbol in the 1-9: GENERAL REQUIREMENTS FOR BASIC
MD SAFETY OF MICROWAVE THERAPY
SAFETY AND ESSENTIAL PERFORMANCE -
following figures. EQUIPMENT
COLLATERAL STANDARD: REQUIREMENTS
a)
Non-inductive components FOR ENVIRONMENTALLY CONSCIOUS IEC 60601-2-7 MEDICAL ELECTRICAL EQUIPMENT – PART
b)
Impedance >> measuring impedance Z DESIGN 2-7: PARTICULAR REQUIREMENTS FOR THE
c)
Z(ƒ) is the transfer impedance of the network, i.e. Vout/in, for a current frequency ƒ. SAFETY OF HIGH-VOLTAGE GENERATORS OF
IEC 60601-1-10 (ADIS) MEDICAL ELECTRICAL EQUIPMENT - PART
DIAGNOSTIC X-RAY GENERATORS
1-10: GENERAL REQUIREMENTS FOR BASIC
Example of a measuring device MD according to IEC 60601-1 and its frequency characteristics
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
14 15
IEC 60601-2-8 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-18 MEDICAL ELECTRICAL EQUIPMENT PART 2: IEC 60601-2-29 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-38 MEDICAL ELECTRICAL EQUIPMENT – PART
2-8: PARTICULAR REQUIREMENTS FOR THE PARTICULAR REQUIREMENTS FOR THE 2-29: PARTICULAR REQUIREMENTS FOR THE 2: PARTICULAR REQUIREMENTS FOR THE
SAFETY OF THERAPEUTIC X-RAY SAFETY OF ENDOSCOPIC EQUIPMENT SAFETY OF RADIOTHERAPY SIMULATORS SAFETY OF ELECTRICALLY OPERATED
EQUIPMENT OPERATING IN THE RANGE 10 HOSPITAL BEDS
IEC 60601-2-19 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-30 MEDICAL ELECTRICAL EQUIPMENT – PART
KV TO 1 MV
2: PARTICULAR REQUIREMENTS OF SAFETY 2-30: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-39 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-9 MEDICAL ELECTRICAL EQUIPMENT – PART OF BABY INCUBATORS SAFETY, INCLUDING ESSENTIAL 2-39: PARTICULAR REQUIREMENTS FOR THE
2: PARTICULAR REQUIREMENTS FOR THE PERFORMANCE, OF AUTOMATIC CYCLING SAFETY OF PERITONEAL DIALYSIS
IEC 60601-2-20 MEDICAL ELECTRICAL EQUIPMENT – PART
SAFETY OF PATIENT CONTACT NON-INVASIVE BLOOD PRESSURE EQUIPMENT
2: PARTICULAR REQUIREMENTS FOR THE
DOSEMETERS USED IN RADIOTHERAPY MONITORING EQUIPMENT
SAFETY OF TRANSPORT INCUBATORS IEC 60601-2-40 MEDICAL ELECTRICAL EQUIPMENT – PART
WITH ELECTRICALLY CONNECTED
RADIATION DETECTORS IEC 60601-2-31 MEDICAL ELECTRICAL EQUIPMENT – PART 2-40: PARTICULAR REQUIREMENTS FOR THE
IEC 60601-2-21 MEDICAL ELECTRICAL EQUIPMENT PART 2:
2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELETROMYOGRAPHS AND
PARTICULAR REQUIREMENTS FOR THE
IEC 60601-2-10 MEDICAL ELECTRICAL EQUIPMENT PART 2: SAFETY OF EXTERNAL CARDIAC EVOKED RESPONSE EQUIPMENT
SAFETY OF INFANT RADIANT WARMERS
PARTICULAR REQUIREMENTS FOR THE PACEMAKERS WITH INTERNAL POWER
SAFETY OF NERVE AND MUSCLE IEC 60601-2-41 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-22 MEDICAL ELECTRICAL EQUIPMENT – PART SOURCE
STIMULATORS 2-41: PARTICULAR REQUIREMENTS FOR THE
2: PARTICULAR REQUIREMENTS FOR THE
IEC 60601-2-32 MEDICAL ELECTRICAL EQUIPMENT PART 2: SAFETY OF SURGICAL LUMINAIRES AND
SAFETY OF DIAGNOSTIC AND THERAPEUTIC
IEC 60601-2-11 MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE LUMINAIRES FOR DIAGNOSIS
LASER EQUIPMENT
PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-
SAFETY OF GAMMA BEAM THERAPY IEC 60601-2-43 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-23 MEDICAL ELECTRICAL EQUIPMENT – PART RAY EQUIPMENT
EQUIPMENT 2-43: PARTICULAR REQUIREMENTS FOR THE
2-23: PARTICULAR REQUIREMENTS FOR THE
IEC 60601-2-33 MEDICAL ELECTRICAL EQUIPMENT – PART SAFETY OF X-RAY EQUIPMENT FOR
SAFETY, INCLUDING ESSENTIAL
IEC 60601-2-12 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE INTERVENTIONAL PROCEDURES
PERFORMANCE, OF
2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAGNETIC RESONANCE
TRANSCUTANEOUSPARTIAL PRESSURE IEC 60601-2-44 MEDICAL ELECTRICAL EQUIPMENT – PART
SAFETY OF LUNG VENTILATORS FOR EQUIPMENT FOR MEDICAL DIAGNOSIS
MONITORING EQUIPMENT 2-44: PARTICULAR REQUIREMENTS FOR THE
MEDICAL USE
IEC 60601-2-34 MEDICAL ELECTRICAL EQUIPMENT – PART SAFETY OF X-RAY EQUIPMENT FOR
IEC 60601-2-24 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-13 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE COMPUTED TOMOGRAPHY
2-24: PARITCULAR REQUIREMENTS FOR THE
2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL
SAFETY OF INFUSION PUMPS AND IEC 60601-2-45 MEDICAL ELECTRICAL EQUIPMENT – PART
SAFETY OF ANAESTHETIC WORKSTATIONS PERFORMANCE, OF INVASIVE BLOOD
CONTROLLERS 245: PARTICULAR REQUIREMENTS FOR THE
PRESSURE MONITORING EQUIPMENT
IEC 60601-2-14 MEDICAL ELECTRICAL EQUIPMENT – PART SAFETY OF MAMMOGRAPHIC X-RAY
IEC 60601-2-25 MEDICAL ELECTRICAL EQUIPMENT – PART
2: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-35 MEDICAL ELECTRICAL EQUIPMENT – PART EQUIPMENT AND MAMMOGRAPHIC
2-25: PARTICULAR REQUIREMENTS FOR THE
SAFETY OF ELECTROCONVULSIVE THERAPY 2: PARTICULAR REQUIREMENTS FOR THE STEREOTACTIC DEVICES
SAFETY OF ELECTROCARDIOGRAPHS
EQUIPMENT SAFETY OF BLANKETS, PADS AND
IEC 60601-2-46 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-26 MEDICAL ELECTRICAL EQUIPMENT PART 2: MATTRESSES, INTENDED FOR HEATING IN
IEC 60601-2-15 MEDICAL ELECTRICAL EQUIPMENT – PART 2-46: PARTICULAR REQUIREMENTS FOR THE
PARTICULAR REQUIREMENTS FOR THE MEDICAL USE
2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF OPERATING TABLES
SAFETY OF ELECTROENCEPHALOGRAPHS
SAFETY OF CAPACITOR DISCHARGE X-RAY IEC 60601-2-36 MEDICAL ELECTRICAL EQUIPMENT – PART
GENERATORS IEC 60601-2-47 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-27 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE
2-47: PARTICULAR REQUIREMENTS FOR THE
2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF EQUIPMENT FOR
IEC 60601-2-16 MEDICAL ELECTRICAL EQUIPMENT – PART SAFETY, INCLUDING ESSENTIAL
SAFETY OF ELECTROCARDIOGRAPHIC EXTRACORPOREALLY INDUCED LITHOTRIPSY
2: PARTICULAR REQUIREMENTS FOR THE PERFORMANCE, OF AMBULATORY
MONITORING EQUIPMENT
SAFETY OF HAEMODIALYSIS EQUIPMENT IEC 60601-2-37 (CCDV) MEDICAL ELECTRICAL EQUIPMENT – PART ELECTROCARDIOGRAPHIC SYSTEMS
IEC 60601-2-28 MEDICAL ELECTRICAL EQUIPMENT – PART 2-37: PARTICULAR REQUIREMENTS FOR THE
IEC 60601-2-17 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-49 MEDICAL ELECTRICAL EQUIPMENT – PART
2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL
2: PARTICULAR REQUIREMENTS FOR THE 2-49: PARTICULAR REQUIREMENTS FOR THE
SAFETY OF X-RAY SOURCE ASSEMBLIES PERFORMANCE OF ULTRASONIC MEDICAL
SAFETY OF REMOTE-CONTROLLED SAFETY OF MULTIFUNCTION PATIENT
AND X-RAY TUBE ASSEMBLIES FOR DIAGNOSTIC AND MONITORING EQUIPMENT
AUTOMATICALLY DRIVEN GAMMARAY MONITORING EQUIPMENT
MEDICAL DIAGNOSIS
AFTER-LOADING EQUIPMENT
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
16 17
IEC 60601-2-50 MEDICAL ELECTRICAL EQUIPMENT – PART
APPENDIX E: PATIENT ENVIRONMENT
2-5O: PARTICULAR REQUIREMENTS FOR
THE SAFETY OF INFANT PHOTOTHERAPY
EQUIPMENT
5m
1.
IEC 60601-2-54 (ANW) MEDICAL ELECTRICAL EQUIPMENT – PART
2-54: PARTICULAR REQUIREMENTS FOR
BASIC SAFETY AND ESSENTIAL
PERFORMANCE OF X-RAY EQUIPMENT FOR
RADIOGRAPHY AND RADIOSCOPY
IEC 60601-2-57 (ANW) PARTICULAR REQUIREMENTS FOR THE Figure G1: Patient Environment
SAFETY AND ESSENTIAL PERFORMANCE OF
INTENSE LIGHT SOURCES USED ON
HUMANS AND ANIMALS FOR MEDICAL AND
COSMETIC PURPOSES
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
18 19
Products in the rigel medical range
Electrical Safety Analyser Electrical Safety Analyser Defibrillator Analyser Ventilator Tester
rigel 266 plus rigel 277 plus rigel 344 rigel 355
WORLD LEADERs IN SAFETY TEST & MEASUREMENT WORLD LEADERs IN SAFETY TEST & MEASUREMENT
20 21
Alslaoble
avafirom
l
Rige
Available online
www.rigelmedical.com
Visit our website and use our regularly updated Knowledge Base for more information
relating to Safety Testing or keep up to date with the latest developments from Rigel
Medical by registering online at www.rigelmedical.com
Copyright 2007 - All rights reserved. No part of this publication may be reproduced, stored in a retrieval
system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording,
scanning or otherwise without prior written consent from SEAWARD GROUP