EN ISO 11138-2:2017

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

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.

Contents Page
European foreword . 3

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.
Endorsement notice
The text of ISO 11138-2:2017 has been approved by CEN as EN ISO 11138-2:2017 without any
modification.
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
ISO 11138-2:2017(E)
© 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
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copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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 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 rights reserved

ISO 11138-2:2017(E)
Introduction
ISO 11138-1 specifies production, labelling, test methods and performance requirements for the
manufacture of biological indicators including inoculated carriers and suspensions intended for use
in validation and monitoring of sterilization processes. This document gives specific requirements for
those biological indicators intended for use in ethylene oxide sterilization processes.
The ISO 11138 series represents the current “state-of-the-art” according to the experts representing
manufacturers, users and regulatory authorities involved in developing the standard. The intent is not
to promote the use of biological indicators where such use is not advised, but rather to provide common
requirements for the production of those biological indicators that are known to be in use today.
Standards exist providing requirements for the validation and control of ethylene oxide sterilization
(see ISO 11135 and ISO 14937).
NOTE It is possible that some countries or regions have published other standards covering requirements
for sterilization or biological indicators.
Advice on selection, use and interpretation of results when using biological indicators can be found in
ISO 14161.
INTERNATIONAL STANDARD ISO 11138-2:2017(E)
Sterilization of health care products — Biological
indicators —
Part 2:
Biological indicators for ethylene oxide sterilization
processes
1 Scope
This document specifies requirements for
...