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ORDIN nr.

261 din 6 februarie 2007


pentru aprobarea Normelor tehnice privind curatarea, dezinfectia i
sterilizarea n unitile sanitare
EMITENT: MINISTE!" S#N#T#$II %!&"I'E
PUBLICAT N: M(NIT(!" ()I'I*" nr+ ,-. din -, februarie -//0
*v1nd n vedere prevederile art+ ,2. alin+ 3,4 din "e5ea nr+ 678-//2
privind reforma n domeniul sntii,
n temeiul 9otr1rii :uvernului nr+ .2-8-//2 privind or5anizarea i
funcionarea Ministerului Sntii %ublice,
vazand eferatul de aprobare al Inspeciei Sanitare de Stat nr+ E+N+
,+-2,8-//0,
ministrul sntii publice emite urmtorul ordin;
*T+ ,
Se aproba Normele tehnice privind curatarea, dezinfectia i sterilizarea
n unitile sanitare publice i private, prevzute n ane<a care face parte
inte5rant din prezentul ordin+
*T+ -
*ne<ele nr+ , ="ista substanelor chimice active permise n produsele
dezinfectante n 'omunitatea European= i nr+ - ="ista standardelor din
om1nia aplicabile n unitile sanitare, n domeniul curatarii, dezinfectiei
i sterilizarii= la normele tehnice se actualizeaz periodic, prin ordin al
ministrului sntii publice, n acord cu re5lementrile europene n domeniu+
*T+ >
"a data intrrii n vi5oare a prezentelor norme tehnice se abro5a (rdinul
ministrului sntii i familiei nr+ ,.78-//> pentru aprobarea Normelor
tehnice privind asi5urarea cureniei, dezinfectiei, efectuarea sterilizarii
i pstrarea sterilitatii obiectelor i materialelor sanitare n unitile
sanitare de stat i private, publicat n Monitorul (ficial al om1niei, %artea
I, nr+ ,6? i ,6? bis din -2 martie -//>, cu modificrile i completrile
ulterioare+
*T+ ?
@ireciile de specialitate din cadrul Ministerului Sntii %ublice,
unitile sanitare publice i private, autoritile de sntate publica
Audeene, respectiv a municipiului &ucureti, i Inspecia Sanitar de Stat
vor duce la ndeplinire prevederile prezentului ordin+
*T+ 7
%rezentul ordin va fi publicat n Monitorul (ficial al om1niei, %artea I+
Ministrul sntii publice,
:heor5he Eu5en Nicolaescu
&ucureti, 2 februarie -//0+
Nr+ -2,+
*NEB*
N(ME TE9NI'E
privind curatarea, dezinfectia i sterilizarea n unitile sanitare
'*%+ I
@efiniii
*T+ ,
Cn sensul prezentului ordin, termenii de mai Aos au urmtoarele
semnificatii;
D autorizaie D actul administrativ prin care produsul biocid este
autorizat pentru plasarea pe piata, pe teritoriul om1niei, de ctre
autoritatea competenta, n urma unei cereri formulate de solicitant, conform
9otr1rii :uvernului nr+ 6728-//7 privind plasarea pe piata a produselor
biocide, cu modificrile i completrile ulterioareE
D nre5istrare D actul administrativ prin care autoritatea competenta, n
urma unei cereri formulate de un solicitant, permite plasarea pe piata, pe
teritoriul om1niei, a unui produs biocid cu risc sczut, dup verificarea
dosarului ce trebuie sa fie conform cu cerinele cuprinse n 9otr1rea
:uvernului nr+ 6728-//7 privind plasarea pe piata a produselor biocide, cu
modificrile i completrile ulterioareE
D curatare D etapa preliminar obli5atorie, permanenta i sistematica n
cadrul oricrei activiti sau proceduri de ndeprtare a murdariei 3materie
or5anic i anor5anica4 de pe suprafee 3inclusiv te5umente4 sau obiecte, prin
operaiuni mecanice sau manuale, utiliz1nduDse a5eni fizici i8sau chimici,
care se efectueaz n unitile sanitare de orice tip, astfel nc1t
activitatea medical sa se desfoare n condiii optime de securitateE
D dezinfecie D procedura de distru5ere a microor5anismelor pato5ene sau
nepato5ene de pe orice suprafee 3inclusiv te5umente4, utiliz1nduDse a5eni
fizici i8sau chimiciE
D produse biocide D substantele active i preparatele conin1nd una sau
mai multe substane active, condiionate ntrDo forma n care sunt furnizate
utilizatorului, av1nd scopul sa distru5a, sa mpiedice, sa fac inofensiva i
sa previn aciunea sau sa e<ercite un alt efect de control asupra oricrui
or5anism daunator, prin miAloace chimice sau biolo5iceE
D substanta activa D o substanta sau un microor5anism, inclusiv un virus
sau o ciuperca 3fun54, ce are o aciune 5eneral sau specifica asupra ori
impotriva or5anismelor duntoareE
D produs deter5entDdezinfectant D produsul care include n compozitia sa
substane care curata i substane care dezinfecteaza+ %rodusul are aciune
dubla; curata i dezinfecteazaE
D dezinfecie de nivel nalt D procedura de dezinfecie prin care se
realizeaz distru5erea bacteriilor, fun5ilor, virusurilor i a unui numr de
spori bacterieni pana la ,/FD?E
D dezinfecie de nivel intermediar 3mediu4 D procedura de dezinfecie prin
care se realizeaz distru5erea bacteriilor n forma ve5etativa, inclusiv
MGcobacterium tuberculosis n forma nesporulata, a fun5ilor i a virusurilor,
fr aciune asupra sporilor bacterieniE
D dezinfecie de nivel sczut D procedura de dezinfecie prin care se
realizeaz distru5erea maAoritii bacteriilor n forma ve5etativa, a unor
fun5i i a unor virusuri, fr aciune asupra micobacteriilor, sporilor de
orice tip, virusilor fr invelis i a muce5aiurilorE
D antiseptic D produsul care previne sau impiedica multiplicarea ori
inhiba activitatea microor5anismelorE aceasta activitate se realizeaz fie
prin inhibarea dezvoltrii, fie prin distru5erea lor, pentru prevenirea sau
limitarea infectiei la nivelul tesuturilorE
D biofilm D caracteristica unui a5ent microbiolo5ic de a adera i a se
fi<a de o suprafata imersata prin secretia unor polimeri, in5reunand astfel
accesul substanelor active antimicrobieneE
D materiovi5ilenta D obli5aia de a declara incidentele sau riscurile de
producere a unor incidente le5ate de utilizarea dispozitivelor medicaleE
D sterilizare D operaiunea prin care sunt eliminate sau omorate
microor5anismele, inclusiv cele aflate n stare ve5etativa, de pe obiectele
inerte contaminate, rezultatul acestei operaiuni fiind starea de sterilitate+
%robabilitatea teoretic a e<istenei microor5anismelor trebuie sa fie mai
mica sau e5ala cu ,/FD2E
D sterilizare chimica D un nivel superior de dezinfecie care se aplica cu
strictee dispozitivelor medicale reutilizabile, destinate manevrelor
invazive, i care nu suporta autoclavarea, realizand distru5erea tuturor
microor5anismelor n forma ve5etativa i a unui numr mare de spori+
'*%+ II
'uratarea
*T+ -
3,4 'urenia reprezint rezultatul aplicrii corecte a unui pro5ram de
curatare+
3-4 Suprafeele i obiectele pe care se evideniaz macroD sau microscopic
materii or5anice ori anor5anice se definesc ca suprafee i obiecte murdare+
*T+ >
'uratarea se realizeaz cu deter5enti, produse de ntreinere i produse
de curatat+
*T+ ?
Cn utilizarea produselor folosite n activitatea de curatare se respecta
urmtoarele re5uli fundamentale;
a4 respectarea tuturor recomandrilor productoruluiE
b4 respectarea normelor 5enerale de protecie a muncii, conform
prevederilor n vi5oareE
c4 este interzis amestecul produselorE
d4 este interzis pstrarea produselor de curatare n ambalaAe alimentareE
e4 produsele se distribuie la locul de utilizare, respectiv la nivelul
seciilor sau compartimentelor, n ambalaAul ori5inal sau n recipiente
special destinate, etichetate cu identificarea produsului+
*T+ 7
3,4 !rmrirea i controlul pro5ramului de curatare revin personalului
unitii sanitare, care, conform le5islaiei n vi5oare, este responsabil cu
suprave5herea i controlul infectiilor nosocomiale din unitate+
3-4 %ro5ramul de curatare i dezinfecie este parte inte5rant a planului
propriu unitii sanitare de suprave5here i control ale infectiilor
nosocomiale+
*T+ 2
@epozitarea produselor i a ustensilelor folosite la efectuarea curatarii
se face respect1nduDse urmtoarele;
a4 n unitatea sanitar, la nivel central, trebuie sa e<iste spaii
special destinate depozitarii produselor i ustensilelor aflate n stoc,
folosite n procesul de efectuare a curatariiE
b4 spaiile trebuie sa asi5ure meninerea calitii iniiale a produselor
pana la utilizareE
c4 spaiile de depozitare trebuie sa ndeplineasc urmtoarele condiii;
D pavimentul i pereii trebuie sa fie impermeabili i uor de curatatE
D zona de depozitare trebuie sa permit aranAarea n ordine a materialelor
de curatare i accesul uor la acesteaE
D trebuie sa e<iste aerisire naturalaE
D trebuie sa e<iste iluminat corespunztorE
D 5radul de umiditate sa fie optim pstrrii calitii produselorE
d4 n fiecare secie sau compartiment trebuie sa e<iste ncperi special
destinate depozitarii produselor i ustensilelor utilizate pentru efectuarea
curatarii, aflate n rulaA, i pentru pre5tirea activitii propriuDziseE
e4 ncperile de depozitare de pe secii, respectiv compartimente, trebuie
sa ndeplineasc urmtoarele condiii;
D pavimentul i pereii trebuie sa fie impermeabili i uor de curatatE
D trebuie sa e<iste aerisire naturalaE
D trebuie sa e<iste iluminat corespunztorE
D locul de or5anizare a activitii, sursa de apa i suprafata zonei de
depozitare trebuie sa permit aranAarea n ordine a materialelor de
ntreinereE
D trebuie sa e<iste chiuveta cu apa potabil rece i calda, dotat pentru
i5iena personalului care efectueaz curatarea, conform prevederilor
le5islaiei n vi5oareE
D trebuie sa e<iste chiuveta sau bazin cu apa potabil, pentru dezinfectia
i spalarea ustensilelor folosite la efectuarea curatariiE dezinfectia,
spalarea i uscarea materialului moale folosit la curatare se pot face
utiliz1nduDse maini de splat cu uscator sau maini de splat i uscatoareE
D trebuie sa e<iste suport uscator pentru manusile de menaA, mopurile,
periile i alte ustensileE
D trebuie sa e<iste pubela i saci colectori de unica folosinta pentru
deeuri, conform le5islaiei n vi5oare+
*T+ 0
3,4 Cntreinerea ustensilelor folosite pentru efectuarea curatarii se face
zilnic, dup fiecare operaiune de curatare i la sf1ritul zilei de lucruE
ustensilele utilizate se spala, se curata, se dezinfecteaza i se usuc+
'uratarea i dezinfectia ustensilelor comple<e se efectueaz n funcie de
recomandrile productorului+
3-4 %ersonalul care e<ecuta operaiunile de curatare i dezinfecie a
materialului de curatare trebuie sa poarte manusi de menaA sau manusi de late<
nesterile+
'*%+ III
@ezinfectia
*T+ .
3,4 @ezinfectia este procedura care se aplica numai dup curatare+ Se face
e<cepie de la aceasta re5ula atunci c1nd pe suportul respectiv sunt prezente
materii or5anice+
3-4 Cn orice activitate de dezinfecie se aplica msurile de protecie a
muncii, conform prevederilor le5islaiei n vi5oare, pentru a preveni
accidentele i into<icatiile+
*T+ 6
Evaluarea dezinfectiei se face prin tehnici specifice descrise n
)armacopeea omana+
*+ @ezinfectia prin miAloace fizice
*T+ ,/
3,4 @ezinfectia prin caldura uscata sau flambarea este utilizata e<clusiv
n laboratorul de microbiolo5ie+
3-4 Este interzis flambarea instrumentului medicoDchirur5ical+
*T+ ,,
@ezinfectia prin caldura umeda se utilizeaz numai n cazul spalarii
automatizate a lenAeriei i a veselei, cu condiia atin5erii unei temperaturi
de peste 6/H'+
*T+ ,-
3,4 @ezinfectia cu raze ultraviolete este indicat n dezinfectia
suprafeelor netede i a aerului n bo<e de laborator, sali de operaii, alte
spaii nchise, pentru completarea msurilor de curatare i dezinfecie
chimica+
3-4 *paratele de dezinfecie cu raze ultraviolete, autorizate conform
prevederilor le5ale n vi5oare, sunt nsoite de documentaia tehnica, ce
cuprinde toate datele privind caracteristicile i modul de utilizare ale
aparatelor, pentru a asi5ura o aciune eficace i lipsit de nocivitate+
&+ @ezinfectia prin miAloace chimice
*T+ ,>
@ezinfectia prin miAloace chimice se realizeaz prin utilizarea produselor
biocide+
*T+ ,?
3,4 %rodusele biocide utilizate n unitile sanitare se ncadreaz n
5rupa principala I, tip de produs , i -, conform ane<ei nr+ - la 9otr1rea
:uvernului nr+ 6728-//7 privind plasarea pe piata a produselor biocide, cu
modificrile i completrile ulterioare+
3-4 &iocidele ncadrate, conform prevederilor le5ale n vi5oare, n tipul
I de produs sunt utilizate pentru;
a4 dezinfectia i5ienica a mainilor prin spalareE
b4 dezinfectia i5ienica a mainilor prin frecareE
c4 dezinfectia pielii intacte+
3>4 &iocidele ncadrate, conform prevederilor le5ale n vi5oare, n tipul
- de produs sunt utilizate pentru;
a4 dezinfectia suprafeelorE
b4 dezinfectia dispozitivelor medicale prin imersie, manual, n bi cu
ultrasunete, sau la maini automateE
c4 dezinfectia lenAeriei 3material moale4+
*T+ ,7
Etichetarea acestor produse trebuie sa respecte prevederile le5islaiei n
vi5oare+
*T+ ,2
@ezinfectia prin miAloace chimice reprezint metoda principala de
prevenire a infectiilor n unitile sanitare+ @ezinfectantul chimic, n
funcie de compoziie i concentraie, poate sa inhibe creterea
microor5anismelor 3bacteriostatic, fun5istatic, virustatic4 sau sa aib o
aciune letala asupra microor5anismelor 3bactericid, fun5icid, virucid,
sporicid4+
*T+ ,0
3,4 @ezinfectantii utilizai n domeniul medical se
autorizeaza8nre5istreaz conform prevederilor le5islaiei n vi5oare+
3-4 Cn domeniul medical nu se utilizeaz biocide la concentratii active n
domeniul casnic+
*T+ ,.
@up natura substanelor chimice care intra n compozitia unui
dezinfectant, acetia se mpart, n funcie de modul de aciune, n
dezinfectanti care acioneaz prin to<icitate celulara i dezinfectanti care
acioneaz prin o<idare celulara+
*T+ ,6
@ezinfectantii care acioneaz prin to<icitate celulara conin substane
active care blocheaza sinteza proteica la nivel citoplasmatic, precum i
proteinele responsabile de replicarea *@NDului sau *NDului microor5anismelor
respective+
*T+ -/
@ezinfectantii care acioneaz prin o<idare celulara conin substane
active care o<ideaza coninutul citoplasmatic inhiband sinteza proteica,
dezmembrand i acizii nucleici purttori ai informaiilor 5enetice+
*T+ -,
Cn funcie de tipul microor5anismelor distruse, de timpul de contact
necesar i de concentratia utilizata, nivelurile de dezinfecie sunt;
a4 sterilizare chimicaE
b4 dezinfecie de nivel naltE
c4 dezinfecie de nivel intermediarE
d4 dezinfecie de nivel sczut+
*T+ --
Sterilizarea chimica realizeaz distru5erea tuturor microor5anismelor n
forma ve5etativa i a unui numr mare de spori bacterieni, n cazul
instrumentarului medical termosensibil+
*T+ ->
Este obli5atorie respectarea concentratiilor i a timpului de contact
specificate n autorizaia8nre5istrarea produsului+
*T+ -?
Etapele sterilizarii chimice sunt;
a4 dezinfecie, cel puin de nivel mediu, urmat de curatareE
b4 sterilizare chimica prin imersieE
c4 clatire cu apa sterila+
*T+ -7
Sterilizarea chimica se realizeaz cu produse biocide
autorizate8nre5istrate, conform prevederilor le5ale n vi5oare+
*T+ -2
3,4 Cn vederea unei corecte practici medicale i a eliminrii oricrui
risc n domeniul sanitar, soluia chimica de sterilizare nu se va folosi mai
mult de ?. de ore de la preparare, n cuve cu capac, sau ma<imum -? de ore, n
cazul utilizrii n instalaii cu ultrasunete+ Cn ambele situaii, numrul
ma<im de proceduri 3cicluri de sterilizare4 este de >/+
3-4 Cn cazul soluiilor care au termen de valabilitate mai mare de ?. de
ore i nu sDa efectuat numrul de proceduri permis, este obli5atorie testarea
concentratiei soluiei cu benzi indicatoare speciale la nceputul fiecrei noi
proceduri, pana la epuizarea celor permise sau pana la termenul ma<im de
valabilitate specificat n fia tehnica a produsului+
*T+ -0
%entru dezinfectia de nivel nalt, intermediar i sczut este obli5atorie
respectarea concentratiilor i a timpului de contact specifice fiecrui nivel
de dezinfecie, care sunt precizate n autorizaia8nre5istrarea produsului+
*T+ -.
Etapele dezinfectiei sunt;
a4 dezinfectia de nivel sczut, urmat de curatare, sau curatarea, n
funcie de suportul ce urmeaz sa fie tratatE
b4 dezinfectia de nivel dorit, n funcie de suportul ce urmeaz sa fie
tratatE
c4 clatirea+
*T+ -6
@ezinfectia se realizeaz cu produse i substane chimice
autorizate8nre5istrate, conform prevederilor le5ale n vi5oare+
*T+ >/
Termenul antiseptic se utilizeaz pentru produsele destinate dezinfectiei
te5umentului i8sau a mainilor+
*T+ >,
'riteriile de utilizare i pstrare corecta a produselor antiseptice sunt
urmtoarele;
,+ un produs antiseptic se utilizeaz numai n scopul pentru care a fost
autorizat8nre5istratE
-+ se respecta ntocmai indicaiile de utilizare de pe eticheta
produsuluiE
>+ se respecta ntocmai concentratia i timpul de contact precizate n
autorizaia8nre5istrarea produsuluiE
?+ pe flacon se noteaza data deschiderii i data limita pana la care
produsul poate fi utilizatE
7+ la fiecare utilizare, flaconul trebuie deschis i nchis corectE
2+ flaconul se manipuleaza cu atentieE este interzis atin5erea 5urii
flaconului, pentru a nu se contaminaE
0+ este interzis transvazarea n alt flaconE
.+ este interzis reconditionarea flaconuluiE
6+ este interzis completarea unui flacon pe Aumtate 5olit n alt flaconE
,/+ este interzis amestecarea, precum i utilizarea succesiva a doua
produse antiseptice diferiteE
,,+ se recomanda ale5erea produselor antiseptice care se utilizeaz ca
atare i nu necesita dilutieE
,-+ sunt de preferat produsele condiionate n flacoane cu cantitate micaE
,>+ dup aplicare, antisepticul nu se indeparteaza prin clatire, deoarece
se pierde efectul remanentE e<cepie fac cele utilizate n neonatolo5ie,
pediatrie i pentru iri5area cavitatilor, la care clatirea este necesar dup
fiecare aplicareE
,?+ se acorda o atentie deosebita compoziiei produsului pentru utilizarea
antisepticului la nouDnscuiE
,7+ se pstreaz numai n flacoanele ori5inale, pentru a se evita
contaminarea lor i pentru a nu se pierde informaiile de pe eticheta
flaconuluiE
,2+ flacoanele trebuie pstrate la adapost de lumina i departe de surse
de caldura+
*T+ >-
I5iena mainilor i dezinfectia pielii se fac dup cum urmeaz;
,+ Spalarea mainilor se face utiliz1nduDse apa i sapunE spalarea i5ienica
a mainilor nu este un substitut pentru dezinfectia i5ienica a mainilor+
-+ @ezinfectia i5ienica a mainilor se face prin spalare sau frecare,
utiliz1nduDse un produs antiseptic+ !n dispenser trebuie utilizat pentru
aplicarea produsuluiE dispenserele trebuie sa fie ntreinute n buna stare de
i5iena i funcionare+
>+ %rocedeul de spalare a mainilor se efectueaz conform informaiilor
furnizate de productor pe eticheta produsuluiE produsul trebuie sa fie
recomandat pentru uz sanitar i trebuie sa fie testat conform standardului EN
,?66, care trebuie sa conin indicaii despre;
a4 necesitatea umectarii prealabile a mainilorE
b4 volumul de produs utilizatE
c4 timpul de spalareE
d4 frecventa aplicrii produsuluiE
e4 instruciunile speciale pentru utilizarea apei+
?+ %rocedeul de frecare a mainilor se efectueaz conform informaiilor
furnizate de productor pe eticheta produsuluiE produsul trebuie sa fie
recomandat pentru uz sanitar i trebuie sa fie testat conform standardului EN
,7//, care trebuie sa conin indicaii despre;
a4 volumul de produs utilizatE
b4 timpul de frecareE
c4 frecventa aplicrii produsului+
7+ @ezinfectia chirur5icala a mainilor prin spalare sau prin frecare este
procedura care se realizeaz numai dup dezinfectia i5ienica a mainilor,
utiliz1nduDse un produs antiseptic+
2+ *ntisepticul se aplica dup cum urmeaz;
a4 pentru suprafeele cutanate sarace n 5lande sebacee;
,+ nainte de efectuarea inAectiilor i punctiilor venoase, cu un timp de
aciune de ,7 secundeE
-+ nainte de efectuarea punctiilor articulatiei, cavitatilor corpului i
or5anelor cavitare, precum i a micilor intervenii chirur5icale, cu un timp
de aciune de minimum un minutE
b4 pentru suprafeele cutanate bo5ate n 5lande sebacee;
,+ naintea tuturor interventiilor chirur5icale se aplica de mai multe ori
pe zona care urmeaz a fi incizata, mentinanduDse umiditatea acesteia, cu un
timp de aciune de minimum ,/ minute+
*ntisepticul poate fi aplicat folosinduDse pulverizarea sau procedura de
ter5ereE dac se folosete procedura de dezinfecie prin ter5ere,
materialele trebuie sa ndeplineasc cerinele pentru proceduri antiseptice
pentru a putea fi folosite+
*T+ >>
%rocedurile recomandate, n funcie de nivelul de risc, se efectueaz
conform tabelului;
ITI

JJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJ
Nivelul de risc %roceduri Indicaii

JJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJJ
Minim D spalarea mainilor sau D c1nd m1inile sunt vizibil murdare
D dezinfectia i5ienica a D la nceputul i la sf1ritul
mainilor prin frecare pro5ramului de lucru
D nainte i dup scoaterea
manusilor
3sterile sau nesterile4
D nainte i dup activitile de
curatare
D nainte i dup contactul cu
pacientii
D dup utilizarea 5rupului sanitar
3K'4
Intermediar D dezinfectia i5ienica a D dup contactul cu un pacient
izolat
mainilor prin frecare sau septic
D dezinfectia i5ienica a D nainte de realizarea unei
mainilor prin spalare proceduri invazive
D dup orice contact accidental cu
san5ele sau cu alte lichide
biolo5ice
D dup contactul cu un pacient
infectat i8sau cu mediul n care
sta
D dup toate manevrele potenial
contaminante
D nainte de contactul cu un pacient
izolat profilactic
D naintea realizrii unei punctii
lombare, abdominale, articulare
sau
similare
D naintea manipulrii
dispozitivelor
intravasculare, tuburilor de dren
pleurale sau similare
D n cazul manevrelor contaminante
efectuate succesiv la acelai
pacient
D nainte i dup n5riAirea
pla5ilor
Cnalt D dezinfectia chirur5icala D nainte de toate interveniile
a mainilor prin frecare chirur5icale, obstetricale
sau D naintea tuturor manevrelor care
D dezinfectia chirur5icala necesita o asepsie de tip
a mainilor prin spalare chirur5ical; montarea cateterelor
centrale, punctii amniotice,
rahidiene i alte situaii
similare

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ISTI
*T+ >?
%entru realizarea unei dezinfectii eficiente se iau n considerare
urmtorii factori care influeneaz dezinfectia;
a4 spectrul de activitate i puterea 5ermicida 3tipul de microor5anism,
rezistenta microor5anismelor4E
b4 natura microor5anismelor pe suportul tratatE
c4 prezenta de material or5anic pe echipamentul8suportul care urmeaz sa
fie tratatE
d4 natura suportului care urmeaz sa fie tratatE
e4 concentratia substanei dezinfectanteE
f4 timpul de contact i temperaturaE
54 susceptibilitatea dezinfectantilor chimici de a fi inactivati de
diferite substane, asa cum este prevzut n autorizaia8nre5istrarea
produsuluiE
h4 tipul de activitate antimicrobiana 3bacterii, virusuri, fun5i4 din care
rezulta eficacitatea produsuluiE
i4 efectul p9DuluiE
A4 stabilitatea produsului ca atare sau a soluiilor de lucru+
*T+ >7
'riteriile de ale5ere corecta a dezinfectantelor sunt urmtoarele;
a4 spectrul de activitate adaptat obiectivelor fi<ateE
b4 timpul de aciuneE
c4 n funcie de secie, acestea trebuie sa aib eficienta i n prezenta
substanelor interferente; s1n5e, puroi, voma, diaree, apa dura, materii
or5aniceE
d4 sa aib remanenta cat mai mare pe suprafeeE
e4 sa fie compatibile cu materialele pe care se vor utilizaE
f4 5radul de periculozitate 3foarte to<ic, to<ic, nociv, coroziv, iritant,
o<idant, foarte inflamabil i inflamabil4 pentru personal i pacientiE
54 sa fie uor de utilizatE
h4 sa fie stabile n timpE
i4 sa fie biode5radabile n acord cu cerinele de mediu+
*T+ >2
'riteriile de utilizare i pstrare corecta a produselor dezinfectante;
a4 un produs dezinfectant se utilizeaz numai n scopul indicat prin
autorizaie8nre5istrareE
b4 se respecta ntocmai indicaiile de utilizare de pe eticheta
produsuluiE
c4 se respecta ntocmai concentratia i timpul de contact indicate n
autorizaie8nre5istrareE
d4 se tine cont de incompatibilitile produsuluiE
e4 niciodat nu se amesteca produse diferiteE
f4 n 5eneral, produsele dezinfectante nu se utilizeaz ca atare, necesita
dilutiiE este de preferat ca soluia respectiva sa se fac n cantitatea
strict necesar i sa se utilizeze imediat, dar nu mai mult de ?. de ore de la
preparareE dac nu este deAa facuta, soluia de lucru ar trebui sa fie
proaspt preparataE
54 soluiile se prepara utiliz1nduDse un sistem de dozare 5radatE
h4 se noteaza pe flacon data preparrii soluiilor respectiveE
i4 se respecta durata de utilizare a soluiilorE n funcie de produs,
aceasta poate varia de la c1teva ore la c1teva sptm1niE
A4 n cazul n care eticheta produsului sDa pierdut, produsul respectiv nu
se mai foloseteE
L4 ntotdeauna manipularea se face purtanduDse echipament de protecieE
l4 se pstreaz numai n flacoanele ori5inale, pentru a se evita
contaminarea lor i pentru a nu se pierde informaiile de pe eticheta
produsuluiE
m4 flacoanele trebuie pstrate la adapost de lumina i departe de surse de
caldura+
'+ e5uli 5enerale de practica a dezinfectiei i a dezinfectantelor
*T+ >0
3,4 @ezinfectia profilactica completeaz curatarea, dar nu o suplineste i
nu poate nlocui sterilizarea+
3-4 Eficienta dezinfectiei profilactice este condiionat de o ri5uroas
curatare prealabil+
3>4 %entru dezinfectia n focar se utilizeaz dezinfectante cu aciune
asupra a5entului pato5en incriminat sau presupusE dezinfectia se practica
nainte de instituirea msurilor de curatare+
3?4 @ezinfectantele trebuie folosite la concentratiile i timpii de
aciune specificati n autorizaie8nre5istrare+
374 Se recomanda utilizarea de cuve cu capac i 5ratar, pentru dezinfectia
instrumentarului+
324 "a prepararea i utilizarea soluiilor dezinfectante sunt necesare;
a4 cunoaterea e<act a concentratiei de lucru n funcie de suportul
supus dezinfectieiE
b4 folosirea de recipiente curateE
c4 utilizarea soluiilor de lucru n cadrul perioadei de stabilitate i
eficacitate, conform unei corecte practici medicale, pentru a se evita
contaminarea i de5radarea sau inactivarea lorE
d4 controlul chimic i bacteriolo5ic, prin sondaA al produselor i
soluiilor dezinfectante n curs de utilizare+
304 !tilizarea dezinfectantelor se face respect1nduDse normele de
protecie a muncii, care sa previn accidentele i into<icatiile+
3.4 %ersonalul care utilizeaz n mod curent dezinfectantele trebuie
instruit cu privire la noile proceduri sau la noile produse dezinfectante+
364 Cn fiecare ncpere n care se efectueaz operaiuni de curatare i
dezinfecie trebuie sa e<iste n mod obli5atoriu un 5rafic zilnic orar, n
care personalul responsabil va inre5istra tipul operaiunii, ora de efectuare
i semnaturaE aceste persoane trebuie sa cunoasc n orice moment denumirea
dezinfectantului utilizat, data preparrii soluiei de lucru i timpul de
aciune, precum i concentratia de lucru+
*T+ >.
%rocesarea suporturilor suprafeelor, instrumentarului i echipamentelor
medicale nainte sau dup utilizare trebuie sa fie corecta, pentru a preveni
infectiile nosocomiale+
*T+ >6
*le5erea metodei de dezinfecie i8sau sterilizare pentru suprafee,
instrumentar i echipamente trebuie sa in cont de cate5oria din care acestea
fac parte i de modul n care sunt folosite n asistenta acordat pacientilor+
%entru dispozitivele medicale invazive este necesar eficacitatea impotriva
mGcobacteriei atipice 3eficacitate mGcobactericida4, procesul trebuind sa fie
eficace impotriva M+ terrae i M+ avium+
*T+ ?/
Suprafeele, instrumentarul i echipamentele sunt clasificate dup cum
urmeaz;
a4 criticeD cele care vin n contact cu sau penetreaza tesuturile corpului
uman, inclusiv sistemul vascular, n mod normal sterile+ Cn aceasta cate5orie
intra; instrumentarul chirur5ical, inclusiv instrumentarul stomatolo5ic,
materialul utilizat pentru suturi, trusele pentru asistenta la natere,
echipamentul personalului din slile de operaii, c1mpuri operatorii, mesele
i tampoanele, tuburile de dren, implanturile, acele i serin5ile, cateterele
cardiace i urinare, dispozitivele pentru hemodializa, toate dispozitivele
intravasculare, endoscoapele invazive fle<ibile sau ri5ide, echipamentul
pentru biopsie asociat endoscoapelor, acele pentru acupunctura, acele
utilizate n neurolo5ieE
b4 semicritice D care vin n contact cu mucoasele intacte, cu e<cepia
mucoasei periodontale, sau cu pielea av1nd soluii de continuitate+ Cn aceasta
cate5orie intra; suprafata interioar a incubatoarelor pentru copii i
dispozitivele ataate acestora 3masca o<i5en, umidificator4, endoscoapele
fle<ibile i ri5ide neinvazive, folosite e<clusiv ca dispozitive pentru
ima5istica, larin5oscoapele, tuburile endotraheale, echipamentul de anestezie
i respiratie asistat, diafra5mele, termometrele de sticla, termometrele
electronice, ventuzele, varfurile de la serin5ile auriculare, specul nazal,
specul va5inal, abaiselan5Durile, instrumentele utilizate pentru montarea
dispozitivelor anticonceptionale, accesoriile pompitelor de lapte+
Suprafeele inerte din secii i laboratoare, stropite cu s1n5e, fecale
sau cu alte secretii i8sau e<cretii potenial pato5ene, i cazile de
hidroterapie utilizate pentru pacientii a cror piele prezint soluii de
continuitate sunt considerate semicriticeE
c4 noncritice D care nu vin frecvent n contact cu pacientul sau care vin
n contact numai cu pielea intact a acestuia+ Cn aceasta cate5orie intra;
stetoscoape, plosti, urinare, manseta de la tensiometru, specul auricular,
suprafeele hemodializoarelor care vin n contact cu dializatul, cadrele
pentru invalizi, suprafeele dispozitivelor medicale care sunt atinse i de
personalul medical n timpul procedurii, orice alte tipuri de suporturi+
Suprafeele inerte, cum sunt pavimentele, pereii, mobilierul de spital,
obiectele sanitare s+a+, se ncadreaz n cate5oria noncritice+
*T+ ?,
Metodele de aplicare a dezinfectantelor chimice n funcie de suportul
care urmeaz sa fie tratat sunt;
ITI

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Suportul de tratat Metoda de aplicare (bservaii

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, - >

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Suprafee
)olosirea dezinfectantelor pentru suprafee, cu respectarea concentratiilor
de utilizare i a timpului de contact, conform recomandrilor

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%avimente 3mozaic, Mter5ere 'uratare ri5uroas, apoi
dezinfecie
ciment, linoleum, 3ce poate fi de nivel sczut, mediu
lemn etc+4 sau nalt ca n cazul prezentei
produselor biolo5ice4

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%erei 3faianta, D Mter5ere Se insista asupra curatarii
prilor
tapet lavabil, D %ulverizareI4 superioare ale pervazurilor i a
uleiati etc+4, usi, altor suprafee orizontale, precum
ferestre 3tocarie4 i ale colturilor, urmat de dezinD
fectie 3ce poate fi de nivel
sczut,
mediu sau nalt ca, de e<emplu, n
cazul prezentei produselor
biolo5ice4

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Mobilier, inclusiv D Mter5ere 'uratare ri5uroas i dezinfecie
de
paturi i noptiere D %ulverizareI4 nivel sczut sau mediu a suprafeD
3din lemn, metal, telor orizontale 3partea superioar
plastic4 a dulapurilor, a rafturilor etc+4

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Mese de operaie, D Mter5ere D 'uratare ri5uroas i dezinfectia
mese instrumentar, D %ulverizareI4 suprafeelor orizontale
suprafee pentru D @ezinfecie de nivel nalt,
pre5tirea curatare, dezinfecie de nivel
tratamentului, nalt ca, de e<emplu, n cazul
suprafee pentru produselor biolo5ice provenite
depozitarea temporar de la pacienti
a produselor
patolo5ice recoltate,
lampi scialitice,
mese de infasat,
mese de lucru
n laborator 3pot
intra i n cate5oria
semicritice4

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Musamale din cauciuc D Mter5ere @ezinfecie de nivel mediu, apoi
sau plastic, colac D Imersie curatare
din cauciuc etc+

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'arucioare, tar5i Mter5ere D 'uratare, dezinfecie de nivel
mediu sau nalt
D Cn funcie de prezenta produselor
biolo5ice de la pacienti, nt1i se
realizeaz dezinfectia de nivel
nalt, apoi se curata

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(biecte sanitare, recipiente de colectare, materiale de curatare
)olosirea dezinfectantelor pentru suprafee, cu respectarea concentratiilor
de utilizare i a timpului de contact, conform recomandrilor

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&i, baite pentru Mter5ere 'uratare, dezinfecie de nivel
mediu
copii, chiuvete, sau nalt
bazine de spalare

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%losti, olite, D Imersie D @up 5olire se folosete , vol+
urinare D Maini soluie dezinfectant nivel mediu
automate pentru , vol+ recipient, curatare,
apoi dezinfecie de nivel nalt
D Se pstreaz uscate n locuri
special destinate

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:rupuri sanitare Mter5ere 'uratare, dezinfecie de nivel
mediu
3K', bazine,
scaune K', pisoare4,
5ratare din lemn
sau plastic pentru
bi i duuri

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Sifoane de Se toarna un produs
pardoseala, sifoane dezinfectant de
de scur5ere nivel sczut

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:aleti pentru Spalare D 'uratare
curatare, ustensile D Cn cazul n care se folosesc la
pentru curatare materii or5anice, nt1i dezinfecie
3perii, mop, teu, de nivel mediu sau sczut, apoi
lavete, carpe etc+4 curatare

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ecipiente pentru Spalare 'uratare, dezinfecie de nivel
sczut
colectarea
deeurilor menaAere,
pubele

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"enAerie i echipament de protecie
)olosirea dezinfectantelor pentru lenAerie, cu respectarea concentratiilor
de
utilizare i a timpului de contact, conform recomandrilor

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"enAerie contaminata Inmuiere n Se pot folosi maini de splat
3murdarita cu e<creD ? litri de automate cu pro5ram de dezinfecie
mente, produse de soluie inclusE necesita predezinfectie
patolo5ice i la , L5 iniial i dezinfecie finala+
lenAerie care de lenAerie
provine de la
bolnavi conta5iosi4

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*lte cate5orii Spalare la maini automate cu ciclu
termic de dezinfecie sau fierbere

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Echipament de Inmuiere Se dezinfecteaza numai cel
protecie contaminat+
i de lucru din
material te<til

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Sorturi Mter5ere 'uratare urmat de dezinfecie
impermeabile din de nivel mediu sau nalt
cauciuc i
plastic

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None de preparare i distribuire alimente
)olosirea dezinfectantelor recomandate pentru uz n bucatarii, oficii
alimentare, dezinfectia veselei, recipientelor, tacamurilor, ustensilelor, cu
respectarea concentratiilor de utilizare i a timpului de contact, conform
recomandrilor

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Oesela, tacamuri, Imersie sau 'uratare, dezinfecie, clatire
alte ustensile ter5ere %entru dezinfecie se utilizeaz un
de consum, produs biocid care se ncadreaz n
echipamente tipul de produs ?+

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Suprafee D Mter5ere 'uratare, dezinfecie, clatire
3pavimente, perei, D %ulverizareI4 %entru dezinfecie se utilizeaz un
mese4 produs biocid care se ncadreaz n
tipul de produs -+

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Instrumentar, echipamente
)olosirea dezinfectantelor pentru instrumentar, cu respectarea concentratiiD
lor de utilizare i a timpului de contact, conform recomandrilor+
Nu se utilizeaz deter5entii casnici, anionici pentru curatarea instrumentaD
rului, echipamentelor+
"a curatare se utilizeaz numai deter5enti special destinai, inclusiv
deter5enti enzimatici urmati de dezinfectanti de nivel nalt+
@ac se utilizeaz dezinfectanti de nivel nalt cu efect de curatare nu se
mai folosesc deter5entii enzimatici, curatarea i dezinfectia av1nd loc
simultan i complet+

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%rocesarea Imersie D @ezinfecie cel puin de nivel
suporturilor mediu i curatare, urmat de
3instrumentar, sterilizare prin caldura
echipamente4 D @ezinfecie cel puin de nivel
critice mediu, curatare, urmat de steriliD
zare chimica 3pentru instrumentarul
care nu suporta sterilizarea prin
caldura4

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%rocesarea D Imersie @ezinfecie de nivel mediu,
curatare
suporturilor D Mter5ere sau dezinfecie de nivel mediu,
3suprafee, pentru urmat de sterilizare chimica
instrumentar, suprafee 3pentru instrumentarul care nu
echipamente4 suporta sterilizarea prin caldura4
semicritice

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Termometre 3orale, D Imersie D @ezinfecie de nivel mediu,
rectale4 D Mter5ere curatare
D Soluii dezinfectante preparate
zilnic
D * nu se amesteca n timpul
procesarii termometrele orale cu
cele rectale

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Incubatoare, Mter5ere D 'uratare urmat de dezinfecie
izolete, masti de de nivel nalt
o<i5en

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'azarmament
)olosirea dezinfectantelor special destinate, de nivel mediu, iar pentru
obiectele care provin de la bolnavii conta5iosi 3&P4, n spaii special
amenaAate, a dezinfectantelor de nivel nalt, n absenta pacientilor

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Saltele, huse %ulverizareI4 Cn spaii etanseizate i n funcie
pentru saltele, de;
perne, paturi, D temperatura
halate din molton, D umiditate relativ
mbrcminte D timpul de e<punere

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Oaporizare 'amera special

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Oaporizare Cn saloane i alte spaii de cazare
i n funcie de;
D temperatura
D umiditate relativ
D timpul de e<punere
@oar n cazuri speciale
3eliminatori
de &P4

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Spaii nchise
)olosirea dezinfectantelor special destinate dezinfectiei aerului, de nivel
nalt, lipsite de to<icitateE se interzice utilizarea aldehidelor de orice
natura+

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Sali de operaie, %ulverizareI4 Cn spaii etanse i n funcie de;
sali de natere, D temperatura
saloane, cabinete D umiditate relativ
D timpul de e<punere

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Oaporizare8 *paratura electronica i de respiD
*erosolizare ratie este proteAata sau scoasa din
spaiul n care se face
dezinfectia+

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@iverse
)olosirea dezinfectantelor pentru suprafee, cu respectarea concentratiilor
de utilizare i a timpului de contact, conform recomandrilor productorului

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Qucarii din D Spalare 'uratare i dezinfecie de nivel
plastic, D Mter5ere nalt sau mediu
cauciuc sau D %ulverizareI4 *tentie clatire
lemn
Qucarii din
material te<til

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Telefoane Mter5ere 'uratare i dezinfecie de nivel
sczut, mediu

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*mbulante, D %ulverizareI4 'uratare i dezinfecie de nivel
miAloace auto D Mter5ere mediu sau nalt

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ISTI
I4 Cn cazul n care dezinfectantul se aplica prin pulverizare se va
utiliza cantitatea specificat n autorizaie8nre5istrare pentru a fi
utilizata pentru un mp sau un mc la timpii recomandai+
*T+ ?-
@ezinfectia curenta i8sau terminala, efectuat numai cu dezinfectanti de
nivel nalt, este obli5atorie n;
a4 seciile de spitalizare a cazurilor de boli transmisibileE
b4 situaia evoluiei unor focare de infectii nosocomialeE
c4 situaiile de risc epidemiolo5ic 3evidentierea cu aAutorul
laboratorului a circulaiei microor5anismelor patone5e4E
d4 seciile cu risc nalt; secii unde sunt asistai pacienti
imunodeprimati, arsi, neonatolo5ie, prematuri, secii unde se practica
5refe8transplant 3de maduva, cardiace, renale etc+4, secii de oncolo5ie i
oncoDhematolo5ieE
e4 blocul operator, blocul de nateriE
f4 seciile de reanimare, terapie intensivaE
54 serviciile de ur5enta, ambulanta, locul unde se triaza lenAeriaE
h4 orice alta situaie de risc epidemiolo5ic identificata+
'*%+ IO
Sterilizarea
*T+ ?>
Sterilizarea face parte din cate5oria procedurilor speciale, ale carei
rezultate nu pot fi verificate inte5ral prin controlul final al produsului,
trebuind sa fie supus validrii, suprave5herii bunei funcionari, precum i
asi5urrii unei pastrari corespunztoare a materialelor sterilizate+
*T+ ??
Sunt obli5atorii controlul permanent al operaiunilor, respectarea
permanenta a procedurilor stabilite, precum i asi5urarea conformitatii
produselor la e<i5enele specificate n standardul EN IS( 6//,8-/// menionat
n ane<a nr+ -+
*T+ ?7
(binerea strii de sterilitate, precum i meninerea ei pana la momentul
utilizrii reprezint o obli5aie permanenta a unitilor sanitare+
*T+ ?2
!nitile sanitare trebuie sa 5aranteze acelai nivel de securitate a
pacientilor, at1t n cazul utilizrii de dispozitive medicale achiziionate de
pe piata, cat i al utilizrii celor sterilizate n unitatea sanitar+
*T+ ?0
Este interzis reprocesarea n vederea reutilizarii a dispozitivelor i
materialelor de unica folosinta+
*T+ ?.
Toate dispozitivele medicale i materialele care urmeaz a fi sterilizate
trebuie dezinfectate, curatate i dezinfectate, nainte de a fi supuse unui
proces de sterilizare standardizat+
*T+ ?6
(r5anizarea activitilor propriuDzise de sterilizare, precum i a
activitilor cone<e, respectiv curatarea, dezinfectia i impachetarea,
stocarea i livrarea, va tine cont de necesitatea respectrii circuitelor, a
evitrii 5olurilor de control pe parcursul realizrii lor i a utilizrii
altor spaii dec1t cele anume desemnate+
*T+ 7/
Serviciul de sterilizare din unitile sanitare de orice tip trebuie sa
fie amenaAat ntrDun spaiu special destinat, n vederea desfurrii
activitilor din etapele menionate+
*T+ 7,
(r5anizarea activitii serviciilor de sterilizare cuprinde;
a4 circuitul de colectare, recipientele i miAloacele de transport pentru
dispozitivele murdare, nesterileE
b4 asi5urarea ariei de curatare n vederea diminurii ncrcturii
microbiene i eliminrii ncrcturii or5anice i a biofilmului de pe
dispozitivele medicaleE
c4 verificarea strii de funcionare a aparaturiiE
d4 spaiul curat pentru inventarierea i impachetarea dispozitivelor
medicaleE
e4 sterilizarea propriuDzisa i sistemul de control al procesuluiE
f4 procedurile de control i marcare a produselor finiteE
54 tratarea neconformitatilorE
h4 nre5istrarea i arhivarea datelor privind parcursul procesului, n
vederea asi5urrii trasabilitatii 3IS( .?/-4, care este un element de sistem
de calitate i este parte componenta a materiovi5ilenteiE
i4 circuitul de stocare, distribuie, transport la utilizatoriE
A4 instruirea personaluluiE
L4 echipamentul de protecie al personalului+
*T+ 7-
'ircuitele se stabilesc astfel nc1t sa asi5ure securitatea personalului,
a mediului i inte5ritatea dispozitivelor medicale+
*T+ 7>
Se efectueaz controlul mediului, conform metodolo5iei prevzute de
)armacopeea omana, n vederea;
a4 evalurii problemelor e<istenteE
b4 remedierii defectiunilorE
c4 suprave5herii i corectrii condiiilor de desfurare a procesului de
sterilizare i a activitilor cone<e+
*T+ 7?
Cn vederea controlului mediului se monitorizeaz i se controleaz;
a4 calitatea aerului, apei i a fluidelor utilizateE
b4 starea de i5iena a suprafeelorE
c4 modul de funcionare a echipamentelor de sterilizareE
d4 modul de funcionare a echipamentelor de control, msura i testareE
e4 inuta i formarea profesional ale personalului+
*T+ 77
Cn unitile de asistenta medical, sterilizarea se realizeaz prin metode
fizice, abur sub presiune sau abur la temperatura i presiune
ridicate8sczute, caldura uscata, precum i prin metode combinate fizicoD
chimice+
*T+ 72
3,4 @ispozitivele medicale care nu suporta sterilizare la temperatura se
sterilizeaza chimic numai cu produse autorizate8nre5istrate+ Cn vederea unei
bune practici medicale i eliminrii oricrui risc n domeniul sanitar, orice
utilizator este obli5at sa in evidenta tuturor procedurilor de sterilizare
chimica n e5istrul de sterilizare chimica+ Se vor completa obli5atoriu;
a4 produsul utilizat i concentratia de lucruE
b4 data i ora preparrii soluiei de lucruE
c4 ora nceperii fiecrei proceduri 3ciclu4 de sterilizareE
d4 lista dispozitivelor medicale sterilizate la fiecare proceduraE
e4 ora terminrii fiecrei proceduri 3ciclu4 de sterilizareE
f4 numele i semnatura persoanei care a efectuat procedura+
3-4 *cest re5istru va fi pus la dispoziia or5anelor de control sanitar i
poate constitui, dup caz, proba medicoDle5al+
*T+ 70
Sterilizarea cu vapori de apa saturati sub presiune trebuie sa fie metoda
de electie, dac dispozitivul medical suporta aceasta procedura+
*T+ 7.
Sterilizarea se realizeaz numai cu aparate de sterilizare autorizate i
avizate conform prevederilor le5ale n vi5oare+
*T+ 76
%resiunea, temperatura i timpul de sterilizare reprezint valori de
si5uranta pentru eficacitatea sterilizarii n funcie de aparat+
*T+ 2/
Trebuie respectate instruciunile de utilizare din cartea tehnica a
aparatului cu privire la temperatura, presiunea i timpul de sterilizare
recomandate de productor, n funcie de tipurile de materiale de sterilizat
ambalate+
*T+ 2,
%ersonalul medical responsabil cu respectarea calitii procedurilor de
sterilizare va fi instruit i calificat pentru fiecare tip de aparat de
sterilizat i va face dovada de certificare a acestui lucru+
*T+ 2-
Instruciunile de utilizare pentru fiecare sterilizator se vor afia la
loc vizibil+
*T+ 2>
"a verificarea calitii sterilizarii la sterilizatorul cu abur sub
presiune, care are sistem de nre5istrare automat a ciclului de sterilizare
dia5rama, se efectueaz analiza acesteia;
a4 prin compararea cu dia5ramaDtip furnizat de productorE
b4 prin analiza dia5ramei, urmrind presiunea i temperatura atinse,
nre5istrate pentru fiecare faza a ciclului, n funcie de pro5ramul ales+
*T+ 2?
"a verificarea calitii sterilizarii la sterilizatorul cu abur sub
presiune care nu are sistem de nre5istrare automat a ciclului de
sterilizare, pe tot parcursul ciclului complet de sterilizare se urmrete pe
panoul de comanda i se noteaza temperatura i presiunea atinse pentru fiecare
faza a ciclului+ Cn aceasta situaie este obli5atorie utilizarea indicatorilor
biolo5ici 3bacteriolo5ici4+
*T+ 27
Se verifica vizual inte5ritatea pachetelor ambalate n h1rtie special sau
pun5i h1rtie plastic, dup care se nchide imediat colierul casoletelor+
*T+ 22
Se verifica obli5atoriu indicatorii fizicoDchimici de eficienta ai
sterilizarii;
a4 virarea culorii benzilor adezive cu indicator fizicoDchimic de lipit pe
cutii, casolete, pachetele ambalate n h1rtie special sau imprimate pe pun5a
h1rtie plasticE
b4 virarea culorii la indicatorii =inte5ratori= plasati n interiorul
fiecrui pachet sau ntrDun pachetelDtest n fiecare cos, verificanduDse
temperatura, timpul i saturatia vaporilor+
*T+ 20
%entru materialele ambalate n pun5i h1rtie plastic, verificarea se poate
face prin transparenta plasticului+ %entru materialele ambalate n cutii
metalice, verificarea se face prin verificarea pacheteluluiDtest atasat la
fiecare cos+
*T+ 2.
Materialul se considera nesterilizat i nu se utilizeaz c1nd virarea
culorii indicatorilor nu sDa realizat+
*T+ 26
Este obli5atoriu controlul umiditatii te<tilelor+
*T+ 0/
3,4 %entru sterilizarea te<tilelor la autoclava, se utilizeaz o casoletaD
test care se plaseaza ntre celelalte casolete n miAlocul ncrcturii+
'asoletaDtest se pre5tete n funcie de dimensiunea acesteia, realizanduDse
o incarcatura cu te<tile, i se plaseaza teste de tifon impaturit, cu o
5reutate de circa -/ 5, n casoleta, n poziiile; sub capac, la miAloc i la
fund, pe a<ul casoletei+ Testele se cantaresc la balana electronica, nainte
de a fi puse n casolete i dup scoaterea de la sterilizare din autoclava+
@iferena de 5reutate e<primat n procent reprezint creterea umiditatii
te<tilelor n cele > puncte investi5ate+
3-4 %entru aparatele la care uscarea se realizeaz n condiii bune,
testele, indiferent de poziia lor n casoleta, indica valori sub 7R 3pentru
autoclavele rom1neti4 sau ,R 3pentru noile tipuri de autoclave4+ Cn caz ca
aceasta norma de umiditate este depit, este obli5atorie verificarea
functionarii autoclavei+
*T+ 0,
)iltrul de la supapa de admisie a aerului atmosferic se schimba conform
recomandrilor productorului aparatului+ Sunt de preferat filtrele de unica
utilizare+ Eficienta filtrului trebuie sa fie de 66,66.R pentru particule de
ordinul de mrime /,> micro 3/,///> mm4+
*T+ 0-
Este interzis funcionarea autoclavelor fr filtru sau cu filtru
carbonizat+
*T+ 0>
'utiile, casoletele, courile, navetele cu pachetele sterilizate se
eticheteaza notanduDse data, ora, sterilizatorul cu abur sub presiune la care
sDa efectuat sterilizarea, persoana care a efectuat sterilizarea+
*T+ 0?
Cn re5istrul de evidenta a sterilizarii se noteaza; data i numrul
autoclavei, atunci c1nd sunt mai multe, coninutul pachetelor din sarAa i
numrul lor, numrul sarAei, temperatura i presiunea la care sDa efectuat
sterilizarea, ora de ncepere i de ncheiere a ciclului 3durata4, rezultatele
indicatorilor fizicoDchimici, semnatura persoanei responsabile cu sterilizarea
i care elibereaz materialul sterilE se ataeaz dia5rama ciclului de
sterilizare 3acolo unde se efectueaz nre5istrarea automat4, rezultatul
testelor biolo5ice, observaii, data la care sDau efectuat ntreinerea i
verificarea aparatului+
*T+ 07
Oerificarea calitii penetrarii aburului se realizeaz zilnic, nainte de
efectuarea primei sterilizari, cu aAutorul testului &oSie T @icL pentru
verificarea calitii penetrarii aburului+
*T+ 02
3,4 Se utilizeaz un pachetDtest compus din prosoape de bumbac de >/8>/
cm, care se pun unul peste altul realizand o nlime de -0,7 cmE n miAlocul
acestora se plaseaza h1rtiaDtest &oSie T @icL de aceeai dimensiune cu
prosopul 3care are imprimat un model 5eometric4+ Se ambaleaza etans ntrDun
camp operator, se nchide cu banda adeziva cu indicator chimic de virare a
culorii+ %achetulDtest astfel confectionat se plaseaza sin5ur n miAlocul
incintei autoclavei+
3-4 Se realizeaz un ciclu de sterilizare complet 3cu preDi
postvacuumare4 la temperatura de ,>?H', timp de >,7 minute+
3>4 "a sf1ritul ciclului complet de sterilizare se e<tra5e din pachet
testul i se interpreteaz rezultatul+ @ac ciclul a fost eficient 3absenta
aerului rezidual sau a pun5ilor de aer4, schimbarea culorii modelului
5eometric imprimat este uniforma+ @ac penetrarea aburului nu a fost uniforma,
au e<istat pun5i de aer, culoarea benzilor este neuniforma 3apar pete mai
clare4+ Cn aceasta situaie, sterilizarea nu a fost eficienta, sterilizatorul
nu trebuie utilizat i se apeleaz la tehnician pentru verificare+
*T+ 00
Testul &oSie T @icL trebuie utilizat;
a4 zilnic, dac la autoclava se sterilizeaza te<tileE
b4 cel puin o data pe saptamana, la autoclavele care sterilizeaza
instrumentarE
c4 dup fiecare reparatie a autoclavei+
*T+ 0.
Cn vederea controlului eficacitatii sterilizarii sunt admii urmtorii
indicatori biolo5ici;
,+ Indicatori biolo5ici cu &acillus stearothermophGllus impre5nati pe
suporti de bumbac sub forma de peticele sau fire de ata n concentratii de
,/FD2 !)'
*cetia se pun n interiorul unei cutiiDtest+ 'utiaDtest se introduce n
autoclava odat cu materialul de sterilizat i se realizeaz ciclul complet de
sterilizare+ "a sf1ritul ciclului, indicatorul biolo5ic este trimis la
laborator, unde este e<tras, insamantat i incubatE citirea se face la 0 zile+
-+ Indicatori biolo5ici cu &acillus stearothermophGllus impre5nati pe
suport i condiionat mpreun cu mediul de cultura infiolat+
"a sf1ritul ciclului se spar5e fiola prin presiune asupra tubului
e<terior i se incubeaza+ 'itirea se face la -? sau ?. de ore+
Se recomanda citirea cu atentie a prospectului i respectarea
recomandrilor productorului+
>+ 'ontrolul bacteriolo5ic al sterilizarii la autoclava cu suspensie de
spori de &acillus stearothermophGllus n soluie nutritiva, cu indicator de p9
Mod de utilizare;
a4 fioleleDtest se introduc n autoclava la diferite niveluri printre
dispozitivele medicale i materialele supuse sterilizarii la ,-/H'+ Se
efectueaz sterilizarea la parametrii indicai de ctre productor 3de
e<emplu, ,-/H', timp de >/ de minute4E
b4 dup sterilizare, fiolele sunt aezate ntrDun incubator de 72H'E
c4 citirea rezultatelor;
D meninerea aspectului 3culoare, transparenta4 nemodificat arata o
sterilizare corectaE
D viraAul la 5alben al indicatorului de p9 i o uoar opalescenta a
coninutului indica o sterilizare sub parametrii de eficienta optima 3au rmas
spori viabili, sDau cultivat i au modificat aspectul produsului4+
*cest test nu este indicat pentru controlul sterilizarii la autoclava la
temperaturi mai mari de ,-/H'+
Modificarea culorii violet a produsului la nuante de violet roscat pana la
5alben, chiar la scoaterea fiolelor din autoclava, indica depirea
temperaturii de ,-/H'+ *ceasta modificare de culoare se datoreaz de5radrii
chimice a substratului din cauza temperaturii ridicate+ *semenea fiole nu mai
este necesar sa fie incubate, deoarece sporii din fiola au fost distrusi+
*T+ 06
3,4 @urata meninerii sterilitatii materialelor ambalate n cutii metalice
perforate sau n casolete cu colier este de -? de ore de la sterilizare, cu
condiia meninerii cutiilor i casoletelor nchise+
3-4 @urata meninerii sterilitatii materialelor ambalate n pun5i h1rtie
plastic sudate este de doua luni de la sterilizare, cu condiia meninerii
inte5ritii ambalaAului+
3>4 @urata meninerii sterilitatii materialelor ambalate n h1rtie
special 3ambalaA n doua straturi de h1rtie, fr soluii de continuitate4
este de o luna de la sterilizare+
*T+ ./
Evaluarea eficacitatii sterilizarii se face;
,+ %entru fiecare ciclu;
a4 pe tot parcursul ciclului complet de sterilizare se urmrete pe panoul
de comanda i se noteaza temperatura i presiunea atinse pentru fiecare faza a
ciclului sau se analizeaz dia5ramaE
b4 se citete virarea culorii indicatorului pentru temperatura de pe banda
adezivaE se citete virarea culorii indicatorului =inte5rator= pentru
sterilizatorul cu abur sub presiune, care controleaz timpul, temperatura i
saturatia vaporilorE
-+ Nilnic;
a4 se controleaz calitatea penetrarii aburului cu aAutorul testului &oSie
T @icLE
b4 controlul cu indicator biolo5ic 3&acillus stearothermophGllus4 pentru
autoclavele din staiile centrale de sterilizare sau pentru autoclavele care
nu sunt echipate cu dispozitiv automat de nre5istrare 3dia5rama4+
*T+ .,
Cntreinerea 3mentenanta4 autoclavelor se efectueaz de un tehnician
autorizat pentru verificarea functionarii acestora, cu periodicitatea
recomandat de productorul aparatului, dar cel puin o data pe trimestru+
*T+ .-
(rice defectiune aparuta la autoclava necesita intervenia tehnicianului
autorizat+
*T+ .>
@up intervenia pe aparat se efectueaz;
a4 verificarea parametrilor aparatului, urmrind nre5istrrile de
temperatura i presiune 3pe panoul frontal sau dia5rama4E
b4 testul &oSie T @icL pentru verificarea calitii penetrarii aburuluiE
c4 controlul umiditatii te<tilelor+
*T+ .?
*mplasarea, dotarea, e<ploatarea, ntreinerea, verificarea i repararea
aparatelor, utilaAelor i instalaiilor de sterilizare se fac conform
prevederilor le5ale n vi5oare+
*T+ .7
Se utilizeaz numai aparate autorizate de Ministerul Sntii %ublice+
*T+ .2
Se vor elabora i afia instruciuni tehnice specifice privind e<ploatarea
aparatelor, precum i msurile ce trebuie luate n caz de avarii, ntreruperi
sau dere5lari la fiecare loc de munca+
*T+ .0
*sistenta medical responsabil cu sterilizarea va fi instruita i
acreditata sa lucreze cu vase sub presiune+
*T+ ..
Sterilizarea apei pentru spalarea chirur5icala se efectueaz n autoclava
pentru sterilizarea apei, potrivit instruciunilor de utilizare din cartea
tehnica a acesteia, la o presiune de sterilizare de ,,7 bari i un timp de
sterilizare de >/ de minute, precum i n diferite aparate, filtre sau alte
dispozitive autorizate conform le5ii+
*T+ .6
eeaua de alimentare i distribuire a apei sterile de la autoclave la
spalatoare trebuie sa ndeplineasc urmtoarele condiii;
a4 distanta ma<ima de la autoclava la punctul de distribuie nu va depi
-/ mE
b4 sunt admise numai conducte fr mufeE
c4 eliminarea oricrei posibiliti de contaminare a apei sterile prin
sta5narea n sistemul de distribuie 3cu interzicerea coturilor n =!= sub
nivelul conductei4E
d4 apa sterila pentru spalarea chirur5icala se prepara n ziua utilizrii
ei+
*T+ 6/
3,4 Sterilizarea la sterilizatoare cu o<id de etilen se utilizeaz doar
c1nd nu e<ista alt miAloc de sterilizare adecvat pentru obiecte i echipamente
termosensibileE aceasta tehnica de sterilizare este delicata i erorile de
procedura pot duce fie la accidente prin sterilizare ineficienta, fie la
accidente to<ice la personal sau pacientii la care se utilizeaz materialul
sterilizat cu o<id de etilen+
3-4 Sterilizarea cu o<id de etilen se efectueaz numai n statia centrala
de sterilizare, special echipata i deservita de personal calificat, instruit
i acreditat sa lucreze cu sterilizatoare cu o<id de etilen+
3>4 Este interzis utilizarea sterilizarii cu o<id de etilen pentru
sterilizarea materialului medicoDchirur5ical n ur5enta+
3?4 Este interzis sterilizarea cu o<id de etilen a materialului medicoD
chirur5ical a crui compoziie nu este cunoscut+
374 Este interzis resterilizarea cu o<id de etilen a echipamentului
medical constituit din pri de policlorura de vinil sterilizat intial cu
radiatii ionizante sau raze 5amma+
324 Este interzis a se fuma n ncperile unde se utilizeaz o<idul de
etilenE aceste ncperi trebuie ventilate n permanenta direct cu aer
proaspt 3din e<terior4+
*T+ 6,
'iclul complet de sterilizare cuprinde urmtoarele faze;
a4 vacuumare iniialE
b4 preincalzireE
c4 ndeprtarea aerului cu umidificarea obiectelorE
d4 sterilizare 3e<punere la 5az4E
e4 vacuumare finalaE
f4 purAare de aer i ventilareE
54 aerare 3desorbtie4+
*T+ 6-
%arametrii pro5ramelor automate de sterilizare sunt;
a4 temperatura de >0H', presiune subatmosferica, timp de sterilizare ,./
de minuteE durata procesului ?D. oreE
b4 temperatura de 77H', presiune subatmosferica, timp de sterilizare 2/ de
minuteE durata procesului -D7 ore+
*T+ 6>
Se admit i ali parametrii ai pro5ramelor automate de sterilizare
specificati n cartea tehnica a aparatului+
*T+ 6?
Este obli5atorie citirea cu atentie a instruciunilor de utilizare i a
crii tehnice a aparatului pentru a folosi temperatura 3presiunea4 i timpul
de sterilizare recomandate de productor pentru materialele de sterilizat
impachetate+
*T+ 67
Oerificarea eficientei sterilizarii se face respect1nd urmtoarele;
a4 citirea i interpretarea dia5ramelor nre5istrate ale ciclului complet
de sterilizare; temperatura, presiunea, presiunea ne5ativa 3vidul4 i durataE
b4 verificarea indicatorilor fizicoDchimici, martori ai trecerii prin
procesul de sterilizare, special fabricati pentru sterilizarea cu o<id de
etilenE
c4 utilizarea pentru fiecare ciclu a testelor biolo5ice 3bacteriolo5ice4
cu spori de &acillus subtillis+
*T+ 62
Cn re5istrul de evidenta a sterilizarii se noteaza; numrul sarAei i
coninutul pachetelor, data i ora de debut i sf1rit ale ciclului,
temperatura la care sDa efectuat sterilizarea, rezultatele indicatorilor
fizicoDchimici i biolo5ici, numele i semnatura persoanei responsabile cu
sterilizarea, observaii, data la care sDa efectuat ntreinerea i
verificarea aparatului+ @ata finala a desorbtiei va fi notat pe fiecare
ambalaA+
*T+ 60
Materialele sterilizate cu o<id de etilen se utilizeaz doar dup ce
coninutul n 5az a sczut sub - ppm 3- m58L54, valoare fi<at prin consens+
*T+ 6.
%entru a respecta prevederea din art+ 6/ se utilizeaz un spaiu ventilat,
cu o temperatura de cel puin -/H', care nu este utilizat n alte scopuri i
n care este interzis stationarea personalului+
*T+ 66
%erioada necesar desorbtiei este n funcie de compozitia materialelor
sterilizate+
*T+ ,//
%entru sterilizatoarele cu o<id de etilen care nu au inclus n ciclul
complet de sterilizare desorbtia la sf1ritul pro5ramului, timpul de desorbtie
necesar pentru echipamente dup e<tra5erea din aparat este;
a4 de ,2 sptm1ni, pentru materiale fabricate din poliamideE
b4 de 2 sptm1ni, pentru materiale fabricate din polietilena, teflon,
late<, silicon, acetat de etilenvinil, poliuretan, polipropilen, %O'
plastifiat+
*T+ ,/,
3,4 Sterilizarea la sterilizatoare cu abur i formaldehida la temperaturi
Aoase i presiune subatmosferica este utilizata n statia centrala de
sterilizare a unitilor sanitare pentru sterilizarea obiectelor,
echipamentelor sensibile la caldura, care pot fi deteriorate la temperaturile
realizate n sterilizatoare cu abur convenionalE a5entul de sterilizare este
formaldehida, utilizata n procesul care are loc la presiune subatmosferica+
3-4 Sterilizarea cu abur i formaldehida la temperaturi Aoase i presiune
subatmosferica se efectueaz numai n statia centrala de sterilizare, special
echipata i deservita de personal calificat, instruit i acreditat sa lucreze
cu astfel de aparate+
3>4 Este interzis utilizarea sterilizarii cu abur i formaldehida la
temperaturi Aoase i presiune subatmosferica pentru sterilizarea materialului
medicoDchirur5ical n ur5enta+
3?4 )ormaldehida 5az ntrDun anumit amestec cu aerul este e<ploziva+
*T+ ,/-
'iclul complet de sterilizare cuprinde urmtoarele faze;
a4 testul de vacuumareE
b4 ndeprtarea aerului cu umidificarea obiectelorE
c4 sterilizarea 3e<punere la formaldehida4E
d4 purAarea aburului i a aeruluiE
e4 aerarea+
*T+ ,/>
%arametrii pro5ramelor automate de sterilizare sunt;
a4 temperatura de 0>H', presiune subatmosferica, timp de sterilizare ,/
minuteE durata procesului >D7 oreE
b4 temperatura de ./H', presiune subatmosferica, timp de sterilizare ,/
minuteE
c4 temperatura de 27H', presiune subatmosferica, timp de sterilizare >/ de
minute+
*T+ ,/?
Se admit i ali parametrii ai pro5ramelor automate de sterilizare
recomandai de productorul aparatului+
*T+ ,/7
Este obli5atorie citirea cu atentie a instruciunilor de utilizare i a
crii tehnice a aparatului pentru a folosi temperatura 3presiunea4 i timpul
de sterilizare recomandate de productor pentru materialele de sterilizat
impachetate+
*T+ ,/2
)ormaldehida este stocata n stare lichid n doze de sticla dimensionate
pentru un sin5ur ciclu de sterilizare+
*T+ ,/0
Sunt obli5atorii achiziionarea i utilizarea de formaldehida mbuteliat
direct de ctre productor+
*T+ ,/.
Oerificarea eficientei sterilizarii se face respect1nd urmtoarele;
a4 vor fi citite i interpretate dia5ramele nre5istrate ale ciclului
complet de sterilizare; se citesc temperatura, presiunea, presiunea ne5ativa
3vidul4 i durataE
b4 indicatorii fizicoDchimici, martori ai trecerii prin procesul de
sterilizare, special fabricati pentru sterilizarea cu formaldehidaE
c4 pentru fiecare ciclu se folosesc teste biolo5ice 3bacteriolo5ice4 cu
spori de &acillus stearothermophGllus+
*T+ ,/6
Cn re5istrul de evidenta a sterilizarii se noteaza; numrul sarAei i
coninutul pachetelor, data i ora de debut i sf1rit ale ciclului,
temperatura la care sDa efectuat sterilizarea, rezultatele indicatorilor
fizicoDchimici i biolo5ici, numele i semnatura persoanei responsabile cu
sterilizarea, observaii, data la care sDau efectuat ntreinerea i
verificarea aparatului+
*T+ ,,/
Se noteaza pe fiecare ambalaA data sterilizarii+
*T+ ,,,
Sterilizarea cu formaldehida se realizeaz n spaii ventilate, destinate
numai pentru aceasta activitate+
*T+ ,,-
Este obli5atoriu controlul periodic al concentratiei n aer a
formaldehidei prin serviciul tehnic al spitalului+
*NEB* ,
la normele tehnice
"IST*
substanelor chimice active permise n
produsele dezinfectante n 'omunitatea European
ITI

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*NEB* -
la normele tehnice
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standardelor din om1nia aplicabile n unitile
sanitare, n domeniul curatarii, dezinfectiei i sterilizarii
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S EN ,-07;-/// *ntiseptice i dezinfectante chimice+ *ctivitatea fun5icida
de baza+ Metoda de testare i prescripii 3faza ,4

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S EN ,-02;-/// *ntiseptice i dezinfectante chimice+ Testul cantitativ al
suspensiei pentru evaluarea activitii bactericide a antiD
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S EN ,27/;-/// *ntiseptice i dezinfectante chimice+ Testul cantitativ al
suspensiei pentru evaluarea activitii fun5icide a
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S EN ,?66;-/// *ntiseptice i dezinfectante chimice+ @ezinfectia i5ienica
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S EN ,?>?.;-//7 *ntiseptice i dezinfectante chimice+ Testul cantitativ al
suspensiei pentru evaluarea activitii micobactericide a
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S EN ,,0?D,;,666 Sterilizarea dispozitivelor medicale+ Estimarea populaiei
de microor5anisme pe produs+
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de microor5anisme pe produs+
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S EN ,>/2/;-//? Sterilizatoare mici cu abur

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S EN ,>.-?;-//7 Sterilizarea dispozitivelor medicale+ Tratarea aseptica a
dispozitivelor medicale lichide+
'erine

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S EN ,?,./;-//? Sterilizatoare pentru scopuri medicale+ Sterilizatoare cu
abur i formaldehida la temperatura Aoasa+ 'erine i
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S EN ,?--;-//> Sterilizatoare de uz medical+ Sterilizatoare cu o<id de
etilen+ 'erine i metode de verificare

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rutina pentru sterilizarea cu caldura umeda

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%artea ,; 'erine pentru dispozitivele medicale sterilizate
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%artea >; Specificaie pentru indicatorii de 'lasa & utiliD
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lor medicale

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,;-//? Evaluare i testare

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S EN IS( ,,,?/D Sterilizarea produselor de n5riAire a sntii+
Indicatori
,;-//2 chimici+ %artea ,; 'erine 5enerale

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S EN IS( @ispozitive medicale+ Sisteme de mana5ement al calitii+
,>?.7;-//? 'erine pentru scopuri de re5lementare

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S EN IS( Sterilizarea dispozitivelor medicale de unica utilizare
,?,2/;-//> cu coninut de materiale de ori5ine animala+ Oalidare i
control de rutina al sterilizarii prin a5eni de
sterilizare
chimici lichizi

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S EN IS( Sterilizarea produselor medicale pentru n5riAirea
,?6>0;-//> sntii+ 'erine 5enerale pentru caracterizarea a5entului
de sterilizare, desfurarea, validarea i controlul de
rutina al proceselor de sterilizare pentru dispozitivele
medicale

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EN IS( 6//,;-/// Sisteme de mana5ement al calitii

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ISTI

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