EN 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)

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
• Publication Date: 16-Apr-2019
• Withdrawal Date: 30-Oct-2019
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 7 - Biological and chemical indicators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Apr-2019
• Completion Date: 17-Apr-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 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)

Relations

• Replaces: EN ISO 14161:2009 - Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
• Effective Date: 24-Apr-2019

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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.
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
ISO 11138-7:2019(E)
© 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
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Published in Switzerland
ii © ISO 2019 – All rights reserved

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 determinatio
...