Tiêu chuẩn iso 11138 2 2017

© ISO 2017 Sterilization of health care products — Biological indicators — Part 2 Biological indicators for ethylene oxide sterilization processes Stérilisation des produits de santé — Indicateurs bio[.]

Sterilization ofhealth car e products —

Part 2:

Biolog ical indicators for eth ylene

Stérilisation de s produits de santé — Indicateurs biolo iques —

Partie 2: Indicateurs biolo iques p ur la stérilisation à l’o yde

d’éth lène

T ir d edition

2 17-0

Reference n mb r

ISO 1 1 8-2:2 17(E)

COPYRIGHT PROTECTED DOCUMENT

© ISO 2017, P blshed in Sw itz rlan

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F reword i v

Introduction v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms an definitions 1

4 General r equirements 1

5 Test or ganism 1

6 Suspensio 2

7 Car rie and pr imar y packag ing 2

8 Inoculated car rier s and biolog ical indicator 2

9 Po ulation and r esistanc e 2

A nne x A (normative) Meth d for deter minatio of resistanc e to ethylene ox ide steri izatio 4

A nne x B (informative)Ratio ale for the inclusio of a sec ond minimum D value specificatio as a r esult of chang es to the test gas used to evaluate r esistanc e and deletio of the requirement for a minimum D value at 30 °C 5

Biblog raphy 6

ISO (he Int ernational Org nization for Stan ardization) is a worldwidefede ation of national s an ards

b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly car ied out

through ISO t ech ical committ ees Each membe b dy int er st ed in a subje t for w hich a t ech ical

committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g ove nmental an non-g ove nmental, in laison with ISO, also take part in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www iso org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sponsible for identifying any or al such p t ent right Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction an / r

on the ISO ls of p t ent de larations r c ived ( e www iso org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

F or an ex lanation on the v lu tary natur of s an ards, the meaning of ISO spe if ic t erms an

ex r s ions r lat ed t o conformity as es ment, as wel as information a out ISO’ s adhe enc t o the

World Trade Org nization (WTO) principles in the Te hnical Bar ie s t o Trade (TBT) se the folowing

URL: www iso org iso / for word html

This document was pr p r d b Te h ical Committ ee ISO/TC 1 8, Ste ii zation o health c ar produc ts

This third edition canc ls an r plac s the se on edition (ISO 1 1 8- 2:2 0 ), w hich has be n

t ech icaly r vised

A l s of al p rt of ISO 1 1 8 can be foun on the ISO websit e

ISO 1 1 8-1 spe if ies prod ction, la el ing, t es methods an pe formanc r q ir ment for the

man factur of biolo ical in icat ors inclu ing inoculat ed car ie s an suspensions int ended for use

in v ldation an monit oring of st eri zation proc s es This document gives spe if ic r q ir ment for

those biolo ical in icat ors int en ed for use in ethy lene o ide st eri ization proc s es

The ISO 1 1 8 se ies r pr sent the cur ent “ tat e-of-the-art” ac ording t o the ex e t r pr senting

man factur rs, use s an r gulat ory a uthorities inv lved in develo ing the s an ard The int ent is not

t o promot e the use of biolo ical in icat ors w he e such useis not advised, but rathe t o pro ide common

r q ir ment for the prod ction of those biolo ical in icat ors that ar known t o be in use t oda

Stan ards exis pro iding r q ir ment for the v ldation an control of ethy lene o ide st eri ization

( e ISO 1 1 5 an ISO 149 7)

NOTE It is pos ible that some cou tries or re ions have p blished other stan ards covering req irements

for st erilization or biolo ical in icat or

A dvic on sele tion, use an int erpr tation of r sult w hen using biolo ical in icat ors can be fou d in

ISO 1416 1

Sterilization ofhealth car e products — Biolog ical

Part 2:

This document spe ifies r q ir ment for t es org nisms, suspensions, inoculat ed car ie s, biolo ical

in icat ors and t es methods int en ed for use in as es ing the pe formanc of st eri iz rs an st eri ization

proc s es emplo ing ethy lene o ide g s as the st eri izing ag ent, eithe as pur ethy lene o ide g s or

mixtur s of this g s with diuent g ses, at st eri zing t empe atur s within the rang e of 2 °C t o 6 °C

NOTE 1 R eq irements for validation an control of ethy lene o ide sterilization proces es are provided by

ISO 1 1 5 an ISO 149 7

NOTE 2 National or re ional re ulations can provide req irements for work place safety

2 Normati ve r eferences

The folowing document ar r fe r d t o in the t ext in such a wa that some or al of their cont ent

cons itut es r q ir ment of this document F or dat ed r fe enc s, only the edition cit ed a ples F or

un at ed r fe enc s, the lat es edition of the r fe enc d document ( inclu ing any amen ment ) a ples

ISO 1 1 8-1:2 1 , Sterili zatio o health c ar produc ts — B iolo ic al indic ators — Part 1: G ene al

r q ir ments

ISO 1 47 , Ste ii zation o health c ar produc ts — B iolo ic al a d chemic al indic ators — Tes t eq ipment

3 Terms and definitions

F or the purposes of this document, the t erms an def initions given in ISO 1 1 8-1 a ply

ISO an IEC maintain t erminolo ical data ases for use in s an ardization at the folowing ad r s es:

— IECEle tro edia: a aia le at ht p:/ www ele tro edia org

— ISO Onlne brow sing plat orm:a ai a le at ht ps:/ www iso org o p/

4 General r equir ements

The r q ir ment of ISO 1 1 8-1 a ply

5 Test or ganism

5.1 The tes or ganisms shal be sp r es of B acillus atro h eu B ac illus subtilis or othe s rains of

micr oor ganisms of demons r ated eq iv lent pe formanc as r eq ir ed b this document

NOTE 1 S me strains of B ac ilus s ubtii s have b en reclas if ied as B ac ilus atr p a us

NOTE 2 B ac ilus atr p a us AT C 9 72, NC C 1 073, NCIMB 8 5 , DSM 2 7 , NRRL B-4418 an CIP 7 1

have b en fou d to b suita le

1)

5.2 If a tes or ganism othe than B acillus atro h eus is used, the suitabi ity of the r esis anc of that tes

or ganism shal be dete mined

The r q ir ment of ISO 1 1 8-1 a ply

7 Car ier and primary packag ing

7.1 The suitabi ty of the car ie and primary p ckag ing mate ials for biolog ical indicators for use in

ethylene o ide s e i zation proc s es shal be demons rated in ac or danc w ith the r eq ir ements of

ISO 1 13 -1:2 1 , 5.2 an A nnex B

7.2 The ex posur e con itions to dete mine complanc shal be

a) minimum ex osur t empe atur : gr at er than or eq al t o 5 °C,

b) st eri zing ag ent:ethy lene o ide g s at a conc ntration not les than 8 0 mg l in air at gr at er than

or eq al t o 7 % RH,

c) ma imum ex osur t empe atur :as s at ed b the biolo ical in icat or man factur r, an

d) ex osur time: gr at er than or eq al t o 6h

NOTE These con itions have b en selected t o represent a re listic chal eng t o the car ier while remaining

within the practical limits of an ethy lene o ide st erilization proces

8 Inoculated car iers and biolog ical indicators

The r q ir ment of ISO 1 1 8-1 a ply

9 P opulation and r esistance

9.1 The manufactur er shal state the r esist anc char acte istics in ac or danc with ISO 1 13

-1:2 1 , 6.4

9.2 The via le cou t shal be stated with increment les than or eq al to 0,1× 10

n

pe unit (e.g pe ml

of suspension, pe inoculated car ie or pe biolog ical in icator)

9.3 For inoculated car ier s an biolog ical in icators, the via le cou t shal be g r eate than or eq al to

1,0 × 10

6

9.4 The r esistanc shal be ex r es ed as the D v lue in min tes, at 54 °C The D v lue of each b tch/lot

of biolog ical in icators or inoculated car ie sshal be s ated in minutes, to one de imal plac at 54 °C

9.5 Suspensions, inoculated car ie s or biolog ical in icators containing B ac illus atro h eus sp r es

shal ha ve a D v lue of not les than 2,5 min at 54 °C when tes ed ac ording to the con itions in A nnex A

using tes gas mix tur es ( e A nnex B) Othe microor ganisms shal ha ve D v lues supp rting the

a plcation

1) T ese ar e examples of suita le pr od cts a vaila le commer cialy T is information is g iven for the con enience

of user of this document an do s not constitute an en or ement by ISO of these pr od cts

9.6 Suspensions, inoculated car ie s or biolog ical in icators containing B acillus atro h eus sp r es

shal ha ve a D v lue of not les than 2,0 min at 54 °C when tes ed ac or ding to the con itions in An ex A

using a tes gas consis ing of 1 0 % EO ( e A nnex B) Othe microor ganisms shal ha ve D v lues

supp rting the a plcation

9.7 The r esistanc characte is ics spe ified in this document an any othe p rts of ISO 1 1 8 shal be

defined using the spe ific c itical v ria les as ociated with ther efer enc d s e i zation proc s

9.8 D v lues ar e dete mined ac ording to methodsg iven in ISO 1 1 8-1:2 1 , A nnex Can A nnex D

9.9 Dete mination of D v lue an surviv l-ki r esp nse char acte is ics req ire the use of a r esis omete

a plying the r efer enc resis omete pr oc s p r amete s ( e A nnex A)

9.10 The surviv l-ki l win ow can be calculated using the formulae in ISO 11 3 -1:2 1 , A nnex E

NOTE T is information can b of value to the user when comparing diferent b tches from the same

man facturer

E AMP E Using the formula in ISO 1 1 8-1:2 17, An e E with the minimum pop lation an minimum D

value req irements specif ied in this document, the survival-kil response charact eristic are:

— at 54 °C, 2,5D value; survival time gre ter than or eq al to 1 min an kil time les than or eq alt o 2 min;

— at 54 °C, 2,0D value; survival time gre ter than or eq al to 8 min an kil time les than or eq alto 2 min

A nnex A

(normative)

Method for determination of resistanc e to ethylene ox ide

A 1 Principle

This method r q ir s the use of a t es a paratus r fe r d t o as a r sist omet er in this document The

spe ifications of the r sist omet er proc s p ramet ers for ethy lene o ide st eri ization proc s es ar

pro ided in ISO 1 47

Spe if ic r q ir ment r lat ed t o the t es method ar pro ided in A.2

A 2 Proc edure

A 2.1 L ad the samples on to suitable sample holde s

A 2.2 Pr eheat the r esis omete chambe to the tes condition of 54 °C

A 2.3 Plac the lo ded sample holde s in the chambe , close the chambe an initiate the tes cycle

A 2.4 C r y out the folowing seq enc of o erations:

— St ep 1: Ev cuat e the chambe t o a v cu m set p int of 1 k a ±0,5 k a

— St ep 2: A dmit suff icient wat er v p ur t o raise the r lative h midity in the chambe t o 6 % ± 1 %

Maintain these con itions for a pe iod of 3 min ± 1min The samples should be alowed t o warm t o

a o e the dew point prior t o inje tion of wat er v p ur t o a oid the pot ential for con ensation

— St ep 3: A dmit ethy lene o ide g s t o the chambe t o o tain a conc ntration of 6 0 mg l ± 3 mg l

within 60 s F or the 0 min ex osur time, no ethy lene o ide g s shal be admitt ed

— St ep 4:Maintain thesecon itions for the r q ir d ex osur time ± s

— St ep 5: A t the en of the ex osur time, ev cuat e the chambe t o 1 kPa or les within 6 s an then

admit f ilt er d air, or an ine t g s ( uch as nitrog en) t o ambient pr s ur

— St ep 6: R epeat st ep 5 four ad itional times or mor if ne es ary t o r d c o e at or ex osur t o any

st eriant r maining in the chambe

— St ep 7 : A t the en of the a o e t es cycle, r mo e the samples from the chambe an trans e the

samples t o the growth medium an incub t e ( e ISO 1 1 8-1:2 1 , Clause 7)

A 2.5 T e trans e pe iod shal be documented an the same time pe iod shal be used for al tes s

A 3 Determination of r esistanc e

R esis anc charact eris ics shal be det ermined ac ording t o methods given in ISO 1 1 8-1:2 1 ,

An exes C, D an E

A nne x B

Rationale for the inclusion of a sec ond minimum D value

specification as a r esult of chang es to the test gas used to evaluate

resistanc e and deletion of the r equirement for a minimum D value

at 30 °C

B.1 Inclusion of a sec ond minimum D value

This document r q ir s D v lue t es ing of ethy lene o ide (EO) biolo ical in icat ors (BIs) in an ISO 1 47

complant r sist omet er using ethy lene o ide g s at a nominal conc ntration of 6 0 mg l Hist oricaly,

this was oft en ac omplshed b BI man factur rs using t es g s mixtur s As of 3 De embe 2 14, the

U.S E A Clean Air A ct prohibit ed the sale an use of HC C-b sed (hydrochlorofluorocarb n)prod ct in

the Unit ed Stat es, r q iring U.S.-b sed BI man factur rs t o chang e the D v lue t es g s from HC C EO

t o 1 0 % EO

R ou d ro in D v lue t es ing at 54 °C complet ed b thr e U.S.-b sed biolo ical in icat or man factur rs

on four dife ent biolo ical in icat or prod ct demons rat ed that D v lues o tained using 1 0 % EO

we e consist ently lowe than D v lues o tained in the HCF /EO mixtur , even though the nominal EO

conc ntration for b th set of t es s was 6 0 mg l The r p rt ed dife enc s between D v lues we e as

high as 40 % This s u y has now be n publ shed in Ph rmaceutic al Te h olo y (2 14 )

[4]

ISO 1 1 8- 2:2 06 has be n amen ed b changing the 54 °C D v lue r q ir ment t o ad an o tion of

a 2,0 min D v lue spe ification for t es s pe formed in 1 0 % EO, based on data r port ed in the pe r

r viewed publcation Pro iding an o tion for BI man factur rs t o maintain compl anc with the

s an ard without changing the actual BI r sis anc was pr fe r d o e driving man factur rs t o

inc ease BI r sis anc t o me t the s an ard This sc nario would c eat e mor risk of p sitive BIs for

en use s w hose st eri ization proc s es we e v ldat ed a ains the lowe r sis anc BIs

B.2 Deletion ofthe r equir ement for a D value at 30 °C

Due t o mis ing data t o sup ort the r q ir ment for a 1 ,5 min t e minimum D v lue at 3 °C, an the

a senc of evidenc for the actual use of this t es method, it hasbe n delet ed from thisdocument