SIST EN ISO 11138-2:2017

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
• Public Enquiry End Date: 29-Nov-2015
• Publication Date: 17-May-2017
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Apr-2017
• Due Date: 30-Jun-2017
• Completion Date: 18-May-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 11138-2:2017 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)

Relations

• Replaces: SIST EN ISO 11138-2:2009 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
• Effective Date: 01-Jun-2017

Overview

EN ISO 11138-2:2017 (CEN / ISO 11138-2:2017) defines requirements for biological indicators used to assess the performance of ethylene oxide (EO) sterilization processes for health care products. It covers test organisms, suspensions, inoculated carriers, biological indicators and test methods for EO sterilizers operating at sterilizing temperatures in the range 29 °C to 65 °C. This part of the ISO 11138 series is specifically focused on EO sterilization and complements the general requirements in ISO 11138-1.

Key topics and technical requirements

• Scope: Biological indicators and test methods for EO sterilization (pure EO or EO/diluent mixtures) at 29–65 °C.
• Test organisms: Primarily spores of Bacillus atrophaeus, Bacillus subtilis, or equivalent strains with demonstrated performance. (Examples of suitable Bacillus atrophaeus strains are listed in the standard.)
• Population: Inoculated carriers/biological indicators must have a viable count of at least 1.0 × 10^6 spores per unit.
• Resistance (D value):
  • Resistance is expressed as the D value (minutes) at 54 °C, stated to one decimal place.
  • For Bacillus atrophaeus spores, minimum D values specified:
    • ≥ 2.5 min at 54 °C when tested with specified test gas mixtures (see Annex B).
    • ≥ 2.0 min at 54 °C when tested with 100% EO test gas.
  • Methods for D-value determination are provided in Annex A.
• Carrier and packaging suitability: Exposure conditions to challenge carriers include:
  • Minimum exposure temperature ≥ 55 °C
  • Ethylene oxide concentration ≥ 800 mg/L in air at ≥ 70% relative humidity
  • Exposure time ≥ 6 hours
  • Maximum exposure temperature as stated by the manufacturer
• Documentation: Manufacturers must state resistance characteristics and viable counts with specified increments.

Applications and users

• Intended for manufacturers and suppliers of biological indicators and inoculated carriers used for EO sterilization monitoring.
• Used by medical device manufacturers, sterile processing departments, hospital sterilization teams, test laboratories and regulatory bodies to:
  • Validate EO sterilization cycles
  • Monitor sterilizer performance and routine biological monitoring
  • Specify and procure compliant biological indicators
• Supports quality assurance and process control in health care product sterilization using ethylene oxide gas.

Related standards

• ISO 11138-1 - General requirements for biological indicators
• ISO 11135 and ISO 14937 - Requirements for validation and control of EO sterilization processes
• ISO 14161 - Guidance on selection, use and interpretation of biological indicator results

Keywords: EN ISO 11138-2:2017, ethylene oxide sterilization, biological indicators, Bacillus atrophaeus, D value, sterilization validation, EO sterilizer performance.

Standards Content (Sample)

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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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 rig
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