Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

This document provides guidance for the selection, use and interpretation of results from application of
biological indicators when used in the development, validation and routine monitoring of sterilization
processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g.
filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and
steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor
vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at
atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 7: Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 11138-7:2019)

Dieses Dokument enthält einen Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen, die durch die Anwendung von biologischen Indikatoren bei der Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren erzielt werden.
Es umfasst keine Verfahren, die ausschließlich auf physikalischer Entfernung von Mikroorganismen, z. B. durch Filtration, beruhen.
Es ist nicht auf Kombinationsverfahren anwendbar, die z. B. Reinigungs /Desinfektionsgeräte verwenden oder das Durchspülen und die Dampfbehandlung von Rohrleitungen.
Es legt keine Anforderungen an die Auswahl und Verwendung biologischer Indikatoren fest, die zur Über-wachung von Verfahren mit verdampftem Wasserstoffperoxid für die Biodekontamination von Isolatoren und Räumen unter Atmosphärendruck vorgesehen sind.
Es gilt nicht für Sterilisationsverfahren mit Flüssigkeitskapselung.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 7: Directives générales pour la sélection, l’utilisation et l’interprétation des résultats (ISO 11138-7:2019)

Le présent document fournit des directives pour la sélection, l'utilisation et l'interprétation des résultats issus de l'application des indicateurs biologiques dans la mise au point, la validation et la surveillance de routine des procédés de stérilisation.
Il ne traite pas des procédés qui reposent uniquement sur l'élimination physique des microorganismes, par exemple la filtration.
Il n'est pas applicable aux procédés fonctionnant en combinaison avec, par exemple, des laveurs-désinfecteurs ou des machines de rinçage et traitement à la vapeur des canalisations.
Il ne spécifie pas les exigences relatives à la sélection et à l'utilisation des indicateurs biologiques destinés à surveiller les procédés au peroxyde d'hydrogène vaporisé pour les isolateurs et les procédés de biodécontamination des pièces à la pression atmosphérique.
Il n'est pas applicable aux procédés de stérilisation par immersion dans un liquide.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 7. del: Navodilo za izbiro, uporabo in predstavitev rezultatov (ISO 11138-7:2019)

Ta dokument podaja navodilo za izbiro, uporabo in predstavitev rezultatov pri uporabi bioloških indikatorjev, kadar se uporabljajo pri razvoju, potrjevanju in rutinskem spremljanju sterilizacijskih postopkov.
Ne upošteva tistih postopkov, ki temeljijo samo na fizičnem odstranjevanju mikroorganizmov, npr. filtriranju.
Ne uporablja se za kombinirane postopke, ki na primer uporabljajo čistilno-dezinfekcijske naprave ali spiranje in parno obdelavo cevovodov.
Ne določa zahtev za izbiro in uporabo bioloških indikatorjev, ki so namenjeni spremljanju postopkov z uplinjenim vodikovim peroksidom pri postopkih biološke dekontaminacije izolatorja in prostorov pri atmosferskem tlaku.
Ne uporablja se za postopke sterilizacije s potopitvijo v tekočino.

General Information

Status
Published
Public Enquiry End Date
14-Nov-2017
Publication Date
03-Jun-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
09-May-2019
Due Date
14-Jul-2019
Completion Date
04-Jun-2019

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SLOVENSKI STANDARD
SIST EN ISO 11138-7:2019
01-julij-2019
Nadomešča:
SIST EN ISO 14161:2010

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 7. del: Navodilo za

izbiro, uporabo in predstavitev rezultatov (ISO 11138-7:2019)

Sterilization of health care products - Biological indicators - Part 7: Guidance for the

selection, use and interpretation of results (ISO 11138-7:2019)

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 7:

Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 11138-

7:2019)

Stérilisation des produits de santé - Indicateurs biologiques - Partie 7: Directives

générales pour la sélection, l’utilisation et l’interprétation des résultats (ISO 11138-

7:2019)
Ta slovenski standard je istoveten z: EN ISO 11138-7:2019
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-7:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11138-7:2019
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SIST EN ISO 11138-7:2019
EN ISO 11138-7
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2019
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 14161:2009
English Version
Sterilization of health care products - Biological indicators
- Part 7: Guidance for the selection, use and interpretation
of results (ISO 11138-7:2019)

Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die

biologiques - Partie 7: Directives générales pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 7:

sélection, l'utilisation et l'interprétation des résultats Leitfaden für die Auswahl, Verwendung und

(ISO 11138-7:2019) Interpretation von Ergebnissen (ISO 11138-7:2019)
This European Standard was approved by CEN on 4 February 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-7:2019 E

worldwide for CEN national Members.
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SIST EN ISO 11138-7:2019
EN ISO 11138-7:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11138-7:2019
EN ISO 11138-7:2019 (E)
European foreword

This document (EN ISO 11138-7:2019) has been prepared by Technical Committee ISO/TC 198

"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102

“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held

by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by October 2019, and conflicting national standards shall

be withdrawn at the latest by October 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 14161:2009.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 11138-7:2019 has been approved by CEN as EN ISO 11138-7:2019 without any

modification.
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SIST EN ISO 11138-7:2019
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SIST EN ISO 11138-7:2019
INTERNATIONAL ISO
STANDARD 11138-7
First edition
2019-03
Sterilization of health care products —
Biological indicators —
Part 7:
Guidance for the selection, use and
interpretation of results
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 7: Directives générales pour la sélection, l’utilisation et
l’interprétation des résultats
Reference number
ISO 11138-7:2019(E)
ISO 2019
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General ............................................................................................................................................................................................................................ 4

5 Characteristics of biological indicators ........................................................................................................................................ 6

5.1 General ........................................................................................................................................................................................................... 6

5.2 Test organism suspension for direct inoculation of products ........................................................................ 7

5.3 Inoculated carriers .............................................................................................................................................................................. 7

5.4 Self-contained biological indicators ..................................................................................................................................... 8

6 Selection of supplier ......................................................................................................................................................................................... 8

6.1 General ........................................................................................................................................................................................................... 8

6.2 Documentation ....................................................................................................................................................................................... 9

6.2.1 General...................................................................................................................................................................................... 9

6.2.2 Manufacturer audit .....................................................................................................................................................10

7 Biological indicators in process development ....................................................................................................................11

7.1 General ........................................................................................................................................................................................................11

7.2 Overkill approach ..............................................................................................................................................................................11

7.3 Combined biological indicator and bioburden method ....................................................................................12

7.4 Bioburden method ............................................................................................................................................................................13

8 Biological indicators in sterilization validation ...............................................................................................................13

8.1 General ........................................................................................................................................................................................................13

8.2 Placement and handling of biological indicators ...................................................................................................14

8.3 Sterilizer qualification ...................................................................................................................................................................14

8.4 Performance qualification ..........................................................................................................................................................14

8.5 Review and approval of validation .....................................................................................................................................15

8.6 Requalification .....................................................................................................................................................................................15

9 Biological indicators in routine monitoring .........................................................................................................................15

9.1 General ........................................................................................................................................................................................................15

9.2 Placement and handling of biological indicators ...................................................................................................16

9.3 Process challenge device .............................................................................................................................................................16

10 Interpretation and acceptance criteria ......................................................................................................................................17

10.1 General ........................................................................................................................................................................................................17

10.2 Interpretation of results ..............................................................................................................................................................17

11 Application of biological indicator standards ....................................................................................................................17

11.1 General assessment of biological indicator performance by the user .................................................17

11.2 Nominal population of test organism ...............................................................................................................................18

11.3 Resistance determination ...........................................................................................................................................................19

11.3.1 General...................................................................................................................................................................................19

11.3.2 Survivor curve method ............................................................................................................................................19

11.3.3 Fraction-negative method .....................................................................................................................................19

11.3.4 Survival-kill response characteristics .........................................................................................................20

11.4 z value determination ....................................................................................................................................................................20

11.4.1 General...................................................................................................................................................................................20

11.4.2 Graphically plotting the z value .................. ......................................................................................................20

11.4.3 Mathematically calculating the z value ......................................................................................................21

11.4.4 Correlation coefficient, r, for the z value ..................................................................................................22

11.5 F equivalent sterilization value determination ..............................................................................................22

(T, z)

11.6 Establishing spore-log-reduction ........................................................................................................................................22

© ISO 2019 – All rights reserved iii
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)

11.7 Sterility assurance level calculation ..................................................................................................................................23

11.8 Test equipment ....................................................................................................................................................................................23

12 Culture conditions............................................................................................................................................................................................24

12.1 General ........................................................................................................................................................................................................24

12.2 Incubation temperature ...............................................................................................................................................................24

12.3 Incubation period ..............................................................................................................................................................................24

12.4 Choice of growth medium ..........................................................................................................................................................25

13 Third-party considerations ....................................................................................................................................................................25

13.1 General ........................................................................................................................................................................................................25

13.2 Minimum requirements from ISO 11138-1 for replicates and total number of

biological indicators ........................................................................................................................................................................26

13.3 Test equipment ....................................................................................................................................................................................26

14 Personnel training ...........................................................................................................................................................................................26

15 Storage and handling ....................................................................................................................................................................................27

16 Disposal of biological indicators .......................................................................................................................................................27

Annex A (informative) Microbiological inactivation kinetics and enumeration techniques ..................28

Annex B (informative) Process challenge devices ...............................................................................................................................33

Annex C (informative) Formulae for D value determination by fraction-negative method ......................34

Annex D (informative) Examples of documentation for biological indicators prepared by

the user ........................................................................................................................................................................................................................50

Annex E (informative) Calculation of z value ............................................................................................................................................54

Annex F (informative) D value determination by survivor curve method ..................................................................57

Annex G (informative) Survival-kill response characteristics ................................................................................................61

Bibliography .............................................................................................................................................................................................................................63

iv © ISO 2019 – All rights reserved
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This first edition cancels and replaces ISO 14161:2009, which has been technically revised.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
© ISO 2019 – All rights reserved v
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)
Introduction

This document provides guidance regarding the selection, use and interpretation of results of biological

indicators used to develop, validate and monitor sterilization processes. The procedures described

in this document are of a general nature and do not, of themselves, constitute a comprehensive

development, validation or monitoring programme with regard to the sterilization of health care

products. The intent of this document is not to stipulate the use of biological indicators in a process

but, if they are used, to provide guidance for their proper selection and use in order to avoid misleading

results.

In this document, users will find guidance on selection of the correct biological indicator for their

particular sterilization process (see the ISO 11138 series) and critical parameters as well as guidance

on its appropriate use.

The selection of an appropriate biological indicator for the particular process used is critical. There is a

wide variety of sterilization processes in common use, and biological indicator manufacturers are not

able to foresee all possible uses of their product. Manufacturers, therefore, label biological indicators

according to their intended use. It is the responsibility of the users of biological indicators to select, use,

recover and interpret the results as appropriate for the particular sterilization process used.

The performance of a biological indicator can be adversely affected by the conditions of storage and

transport prior to its use, by inappropriate/non-indicated use of the biological indicator or by the

sterilizer process parameters. In addition, the incubation procedure used after exposure to the process,

including incubation temperature and culture medium type, supplier and specific batch, can affect

measured resistance as a function of recovery and growth. For these reasons, the recommendations

of the biological indicator manufacturer for transportation, storage and use should be followed. After

exposure, the aseptic transfer (if applicable) and incubation of biological indicators as specified by the

biological indicator manufacturer is critical for obtaining correct results.

It is important to note that biological indicators are not intended to indicate that the products in the

load being sterilized are sterile. Biological indicators are utilized to test the effectiveness of a given

sterilization process and the equipment used, by assessing microbial lethality according to the concept

of sterility assurance level. Suitable training is necessary for personnel conducting these studies.

NOTE The general information provided in this document can have useful application for processes and

biological indicators not currently addressed by existing International Standards, e.g. new and developing

sterilization processes.
vi © ISO 2019 – All rights reserved
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SIST EN ISO 11138-7:2019
INTERNATIONAL STANDARD ISO 11138-7:2019(E)
Sterilization of health care products — Biological
indicators —
Part 7:
Guidance for the selection, use and interpretation of results
1 Scope

This document provides guidance for the selection, use and interpretation of results from application of

biological indicators when used in the development, validation and routine monitoring of sterilization

processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g.

filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and

steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor

vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at

atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
aseptic technique

conditions and procedures used to minimize the risk of the introduction of microbial contamination

[SOURCE: ISO 11139:2018, 3.16]
3.2
bioburden

population of viable microorganisms on or in a product and/or sterile barrier system

[SOURCE: ISO 11139:2018, 3.23]
© ISO 2019 – All rights reserved 1
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)
3.3
biological indicator

test system containing viable microorganisms providing a specified resistance to a specified

sterilization process
[SOURCE: ISO 11139:2018, 3.29, modified — "BI" has been added to term.]
3.4
D value
D value

time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test

microorganisms
[SOURCE: ISO 11139:2018, 3.75]
3.5
holding time

period during which process parameters are maintained, within their specified tolerances

[SOURCE: ISO 11139:2018, 3.133]
3.6
inoculated carrier

supporting material on or in which a specified number of viable test microorganisms has been deposited

[SOURCE: ISO 11139:2018, 3.144]
3.7
inoculation

addition of a defined amount of a characterized microbial entity into or on to an item

3.8
log reduction
reduction in number of viable microorganisms
Note 1 to entry: Expressed in log units.
3.9
operational qualification

process of obtaining and documenting evidence that installed equipment operates within predetermined

limits when used in accordance with its operational procedures
[SOURCE: ISO 11139:2018, 3.220.3]
3.10
performance qualification

process of establishing by objective evidence that the process, under anticipated conditions, consistently

produces a product which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.11
process challenge device
PCD

item providing a defined resistance to a cleaning, disinfection, or sterilization process and used to

assess performance of the process
[SOURCE: ISO 11139:2018, 3.205]
2 © ISO 2019 – All rights reserved
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SIST EN ISO 11138-7:2019
ISO 11138-7:2019(E)
3.12
process challenge location
PCL

site chosen within a load as the position at which the least microbiological inactivation is expected to

be delivered
[SOURCE: ISO 11139:2018, 3.206]
3.13
process parameter
specified value for a process variable

Note 1 to entry: The specification for a process includes the process parameters and their tolerances.

[SOURCE: ISO 11139:2018, 3.211]
...

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