Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2017)

Dieses Dokument legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung von Sterilisatoren und Sterilisationsverfahren vorgesehen sind, die Ethylenoxidgas als sterilisierendes Agens verwenden, entweder als reines Ethylenoxidgas oder als Gemische dieses Gases mit Verdünnungsgasen bei Sterilisiertemperaturen im Bereich von 29 °C bis 65 °C.
ANMERKUNG 1   Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit Ethylenoxid sind in ISO 11135 und ISO 14937 angegeben.
ANMERKUNG 2   Anforderungen an die Sicherheit am Arbeitsplatz könnten in nationalen oder regionalen Bestimmungen angegeben sein.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2017)

ISO 11138-2:2017 spécifie les exigences spécifiques applicables aux organismes d'essai, aux suspensions, aux porte-germes inoculés, aux indicateurs biologiques et aux méthodes d'essai prévus pour être utilisés dans l'évaluation des performances des stérilisateurs et des procédés de stérilisation qui ont recours à l'oxyde d'éthylène comme agent stérilisant, soit sous forme d'oxyde d'éthylène pur soit sous forme de mélanges de ce gaz et de gaz diluants, à des températures de stérilisation comprises entre 29 °C et 65 °C.
NOTE 1 Les exigences de validation et de contrôle des procédés de stérilisation à l'oxyde d'éthylène sont fournies par l'ISO 11135 et l'ISO 14937.
NOTE 2 Des réglementations nationales ou régionales peuvent fournir des exigences relatives à la sécurité du lieu de travail.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2017)

Ta dokument določa zahteve za preskusne organizme, suspenzije, vcepljene prenašalce in biološke indikatorje ter preskusne metode za uporabo pri vrednotenju učinkovitosti sterilizatorjev in sterilizacijskih postopkov, ki kot sterilizacijsko sredstvo uporabljajo etilenoksidov plin, ali kot čisti etilenoksidov plin ali mešanice tega plina in plinov za redčenje, pri temperaturah za sterilizacijo v razponu od 29 °C do 65 °C.
OPOMBA 1: zahteve za potrjevanje in nadzor sterilizacijskih postopkov z etilenoksidom zagotavljata standarda ISO 11135 in ISO 14937.
OPOMBA 2: zahteve za varnost na delovnem mestu lahko zagotavljajo nacionalni ali regionalni predpisi.

General Information

Status
Published
Publication Date
28-Mar-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
29-Mar-2017
Completion Date
29-Mar-2017

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SLOVENSKI STANDARD
SIST EN ISO 11138-2:2017
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-2:2009

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki

indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2017)

Sterilization of health care products - Biological indicators - Part 2: Biological indicators

for ethylene oxide sterilization processes (ISO 11138-2:2017)

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2:

Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2017)

Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs

biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-2:2017
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-2:2017 en

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

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SIST EN ISO 11138-2:2017
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SIST EN ISO 11138-2:2017
EN ISO 11138-2
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-2:2009
English Version
Sterilization of health care products - Biological indicators
- Part 2: Biological indicators for ethylene oxide
sterilization processes (ISO 11138-2:2017)

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

biologiques - Partie 2: Indicateurs biologiques pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 2:

stérilisation à l'oxyde d'éthylène (ISO 11138-2:2017) Biologische Indikatoren für Sterilisationsverfahren mit

Ethylenoxid (ISO 11138-2:2017)
This European Standard was approved by CEN on 19 January 2017.

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: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-2:2017 E

worldwide for CEN national Members.
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SIST EN ISO 11138-2:2017
EN ISO 11138-2:2017 (E)
Contents Page

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

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SIST EN ISO 11138-2:2017
EN ISO 11138-2:2017 (E)
European foreword

This document (EN ISO 11138-2:2017) 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 September 2017 and conflicting national standards

shall be withdrawn at the latest by September 2017.

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

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.
This document supersedes EN ISO 11138-2:2009.

The standard is a full technical revision of the previous version. The following amendments have been

made in comparison with EN ISO 11138-2:2009:

— requirements on population and resistance (clause 9) revised, e.g. information to minimum D-value

at 30 °C deleted;
— Annex A, in particular A.2.4 step 6 revised;

— informative Annex B on rationale for the inclusion of a second D-value and deletion of the

requirement for a minimum D-value at 30 °C added;

— informative Annex ZA respective relationship between this European Standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered was deleted.

EN ISO 11138 consists of the following parts, under the general title Sterilization of health care

products — Biological indicators:
— Part 1: General requirements
— Part 2: Biological indicators for ethylene oxide sterilization processes
— Part 3: Biological indicators for moist heat sterilization processes
— Part 4: Biological indicators for dry heat sterilization processes

— Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

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.
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SIST EN ISO 11138-2:2017
EN ISO 11138-2:2017 (E)
Endorsement notice

The text of ISO 11138-2:2017 has been approved by CEN as EN ISO 11138-2:2017 without any

modification.
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SIST EN ISO 11138-2:2017
INTERNATIONAL ISO
STANDARD 11138-2
Third edition
2017-03
Sterilization of health care products —
Biological indicators —
Part 2:
Biological indicators for ethylene
oxide sterilization processes
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 2: Indicateurs biologiques pour la stérilisation à l’oxyde
d’éthylène
Reference number
ISO 11138-2:2017(E)
ISO 2017
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SIST EN ISO 11138-2:2017
ISO 11138-2:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 11138-2:2017
ISO 11138-2:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 General requirements ..................................................................................................................................................................................... 1

5 Test organism ........................................................................................................................................................................................................... 1

6 Suspension .................................................................................................................................................................................................................. 2

7 Carrier and primary packaging ............................................................................................................................................................ 2

8 Inoculated carriers and biological indicators ........................................................................................................................ 2

9 Population and resistance .......................................................................................................................................................................... 2

Annex A (normative) Method for determination of resistance to ethylene oxide sterilization ..............4

Annex B (informative) Rationale for the inclusion of a second minimum D value

specification as a result of changes to the test gas used to evaluate resistance and

deletion of the requirement for a minimum D value at 30 °C ................................................................................ 5

Bibliography ................................................................................................................................................................................................................................ 6

© ISO 2017 – All rights reserved iii
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SIST EN ISO 11138-2:2017
ISO 11138-2:2017(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 on 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 the following

URL: w w w . i s o .org/ iso/ foreword .html.

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

This third edition cancels and replaces the second edition (ISO 11138-2:2006), which has been

technically revised.
A list of all parts of ISO 11138 can be found on the ISO website.
iv © ISO 2017 – All rig
...

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