Tiêu chuẩn iso 11138 3 2017

© ISO 2017 Sterilization of health care products — Biological indicators — Part 3 Biological indicators for moist heat sterilization processes Stérilisation des produits de santé — Indicateurs biologi[.]

Sterilization ofhealth car e products —

Part 3:

Stérilisation de s produits de santé — Indicateurs biolo iques —

Partie 3: Indicateurs biolo iques p ur la stérilisation à la ch leur

h mide

T ir d edition

2 17-0

COPYRIGHT PROTECTED DOCUMENT

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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 moist he t ster ilzation 4

A nne x B (normative) Calculatio of z value and c oeficient of determinatio , r 2 5

Biblog raphy 8

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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 8-3:2 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

This document spe if ies prod ction, la el ng, 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 mois heat st eri ization proc s es

Mois heat as the st eri zing ag ent is defined in this document as dry saturat ed st eam Whie air-st eam

mixtur s can be used in mois heat st eri ization proc s es, the methods an pe formanc r q ir ment

of this document might not be a pl ca le for biolo ical indicat ors used in such 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 involved in develo ing the s andard The int ent is

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

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

Stan ards exis pro iding r q ir ment for the v ldation an control of mois heat st eri ization ( e

ISO 1766 se ies)

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 3:

Biolog ical indicators for moist heat sterilization pr oc esses

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

in icat ors an t es methods int en ed for use in as es ing the pe formanc of st eri zation proc s es

emplo ing mois heat as the st eri zing ag ent

NOTE 1 R eq irements for validation an control of moist he t sterilization proces es are provided by the

ISO 17 665 series

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 p:/ 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 res of Geo acillus stearothe mo hilus or othe s rains of

micr oor ganism of demons rated eq iv lent pe formanc as req ired b this document

NOTE 1 B ac ilus te r th rmo hius has b en reclas if ied as G eo ac ilus te r th rmo hius

NOTE 2 G eo ac ilus s e r th rmo hius AT C 79 3 (NC C 1 0 7, DSM 2 an CIP 5 8 ), AT C 1 9 0

(eq ivalent to NRRL B-4419)have b en fou d t o b suita le

1)

1][2]

5.2 If a tes or ganism othe than G eo ac illus s tearothe mo hilus or B acillus subtilis ATC 3 0 1 (5 3 )

is used, the suitabi ty of the resistanc of that es or ganism shal be dete mined

NOTE For proces es at les than 1 1 °C, mic o rg nisms such as B ac ilus s ubtii s AT C 3 0 1 (5 3 ) could

b used,particularly in sterilization of he t-sensitive liq ids

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 an primary p ckag ing mate ials for biolog ical in icators for use

in mois heat s e i zation pr oc s es shal be demons rated in ac ordanc with 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 a ove the man factur r’ s s at ed

ma imum ex osur t empe atur ,

b) st eri zing ag ent: dry saturat ed st eam; if the biolo ical in icat or is int en ed for use in a mois

heat proc s not using dry saturat ed st eam, e.g an air/st eam mixtur , the a pro riat e air st eam

mixtur should be used an not ed as an ex ception t o this document,

c) ma imum ex osur t empe atur : as s at ed b theman factur r; if not s at ed b the man factur r,

a t empe atur of 140 °C shal be used, an

d) ex osur time: gr at er than or eq al t o 3 min

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 a moist he t sterilization 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 incr ement 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

5

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

9.4 The r esis anc shal be ex pr es ed as the D v lue in min tes at 1 1 °C Additional temperatur e( )

ma y be sele ted b the man factur er The D v lue of each b tch/lot of biolog ical in icatorsor inoculated

car ie s shal be s ated in min testo one de imal plac at 1 1 °C

9.5 Suspensions, inoculated car ie s or biolog ical in icators containing G eo acillus stearothe mo hilus

spores shal ha ve a D

1 1

v lue of g r eate than or eq al to 1,5 min when tes ed ac ording to the conditions

g iven in An ex A Othe micr oor ganisms shal ha ve D v lues sup orting the a plcation The z v lue of

the tes or ganisms in the suspension, on the inoculated car ie or in the biolog ical indicator shal be

dete mined at not les than thr ee temperatur es, in the rang e of 1 0 °C to 1 8 °C T ese data shal be used

to calculate the z v lue, which shal be g r eate than or eq al to 6 °C ( e A nnex B)

9.6 The r esistanc char acte is ics spe ified in this document an any othe p rt 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

9.7 D v lues ar e deter mined ac ording to methodsg iven in ISO 1 1 8-1:2 1 , A nnexes C an D

9.8 Dete mination of D v lue and surviv l-ki r esp nse char acte is ics req ires the use of a

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

9.9 The surviv l-ki 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 1 1 °C: survival time gre ter than or eq al to 4,5min an kil time les than or eq al t o 1 ,5 min

A nnex A

(normative)

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 if ications of the r sist omet er proc s p ramet ers for mois heat 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 tes samples on to suitable sample holde s

A 2.2 Pr e-heat the r esis omete chambe to the req ir ed o erating temperatur e, e.g 12 °C ± 0,5 °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 set p int of 4,5 k a ± 1 k a within 2 min

— St ep 2: A dmit st eam t o the chambe t o o tain the r q ir d t empe atur an pr s ur within 1 s

F or the 0 min t e ex osur time, no st eam shal be admitt ed

— St ep 3: Maintain these con itions for ther q ir d ex osur time

— St ep 4: A t the en of the ex osur pe iod, ev cuat e the chambe ; then admit filt er d air t o ambient

pr s ur The time taken t o achieve 1 0 k a shal be 1 sor les

— St ep 5: A t the en of the a o e t es cycle, r mo e the samples from the chambe , and co l down

ra idly 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

(normative)

Calculation of z value and c oef icient of deter mination, r

2

B.1 Using al the data o tained from eithe ISO 1 1 8-1:2 1 , A nnex Cor ISO 1 1 8-1:2 1 , A nnex D,

plot the lo

1

of the D v lue agains ex posur e temperatur e in deg rees Celsius T e z v lue is eq al to the

negative recipr ocal of the slo e of the bes -fit recti near curve as dete mined b r eg res ion analysis

NOTE S e 9.5 for req irements re arding calculation of z value an co ff icient of determination, r

2

B.2 The slo e of the best-fit r ectilnear curve is calculated using F rmula (B.1):

m

=

( )

−

( )

−

( ) 2

(B.1)

w he e

m is theslo eof the bes -fit r cti inear curve;

n is then mbe of D v lue /t empe atur p irs;

G

=









∑

t lo y

1

;

A

=

( )

∑

t ;

B

1 y

∑

;

C

=

( )

∑

t ;

t is ex osur time;

γ is minimum D v lue

The data r q ir d for the calculation ar given in Ta le B.1

Table B.1 — Examples of data colected for re res io analy sis

D v lue

(min)

y

E p sur

t empe atur

( C)

t

lo

1

1

1 y) 2

y

1

1 y

1

(t ) 2

t (lo

1 y

1

1 y

1 ) 2

y

2

1 y

2

(t ) 2

t (lo

1 y

2

1 y

2 ) 2

y

3

1 y

3

(t ) 2

t (lo

1 y

3

1 y

3 ) 2

y

n

1 y

n

(t ) 2

t (lo

1 y

n

1 y

n ) 2

i

i

i n

=

=

=

∑

1

i

i

i n

=

=

=

∑ log

1

1

i

i

i n

=

( )

=

=

∑

1 2

i

i n

=











=

=

∑ log

1

1

i

i

i n

=

=

=

∑ log

1

1

2

As igned

varia le

B.3 Ta le B.2 shows example calculations for the slo e of the bes -fit r ecti near curve

Table B.2 — Examples of calculatio s for slo e

D v lue

(min)

y

E p sur

t empe atur

( C)

t

lo

1

1

1 y) 2

y

1

1 y

1

= 0,3 1 0 (t )

2

= 14 41 t (lo

1 y

1 ) = 36,42 0 (lo

1 y

1 ) 2

= 0,0 0 6

y

2

= 1,1 t = 1 4 lo

1 y

2

=0,041 4 (t )

2

= 1 3 7 6 t (lo

1 y

2 )= 5,1 3 6 (lo

1 y

2 ) 2

=0,0 1 7

y

3

= 0,4 t = 1 9 lo

1 y

3

= − 0,3 7 9 (t )

2

= 16 41 t (lo

1 y

3 )= − 5 ,3 9 1 (lo

1 y

3 ) 2

= 0,1 8 3

i

i i

=

=

=

∑

1 3

i

i i

=

=

=

∑ log

1

1 3

i

i i

=

( )

=

=

∑

1

3 2

i i

=











=

=

∑ log

1

1 3

i

i i

=

=

=

∑ log

1

1

5

2

As igned

varia le

m

=

( )

−

( )

−

2

m =

( )

−











−

−





















−

3 46 6 8

3 4 2

m =

−

− −

−

1 99 4 1 98 6

m =

−8 5 65

9

,

m =−0,0 7 4