Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

ISO 11138-2:2006 provides specific 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.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)

Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2006)

L'ISO 11138-2:2006 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.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2006)

General Information

Status
Withdrawn
Publication Date
05-May-2009
Withdrawal Date
28-Mar-2017
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
29-Mar-2017

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SLOVENSKI STANDARD
SIST EN ISO 11138-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 11138-2:2006

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

indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2006)

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

for ethylene oxide sterilization processes (ISO 11138-2:2006)

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

Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)

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

biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-2:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-2:2009 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11138-2:2009
---------------------- Page: 2 ----------------------
SIST EN ISO 11138-2:2009
EUROPEAN STANDARD
EN ISO 11138-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.01 Supersedes EN ISO 11138-2:2006
English Version
Sterilization of health care products - Biological indicators - Part
2: Biological indicators for ethylene oxide sterilization processes
(ISO 11138-2:2006)

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

- Partie 2: Indicateurs biologiques pour la stérilisation à Biologische Indikatoren - Teil 2: Biologische Indikatoren für

l'oxyde d'éthylène (ISO 11138-2:2006) Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)

This European Standard was approved by CEN on 19 April 2009.

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 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 Management Centre has the same status as the

official versions.

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

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-2:2009: E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11138-2:2009
EN ISO 11138-2:2009 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC ...........................................................................................4

---------------------- Page: 4 ----------------------
SIST EN ISO 11138-2:2009
EN ISO 11138-2:2009 (E)
Foreword

The text of ISO 11138-2:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health

care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO

11138-2:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” 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 November 2009, and conflicting national standards shall be withdrawn

at the latest by March 2010.

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 11138-2:2006.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EC Directive.

For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.

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, Cyprus, Czech

Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
Endorsement notice

The text of ISO 11138-2:2006 has been approved by CEN as a EN ISO 11138-2:2009 without any

modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 11138-2:2009
EN ISO 11138-2:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide a means of conforming to Essential Requirements of the

New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has

been implemented as a national standard in at least one Member State, compliance with the clauses of this

standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity

with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA – Correspondence between this European Standard and Directive 93/42/EEC on medical

devices

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes

EN of Directive 93/42/EEC
4 5, 13 The requirements of
ISO 11138-1 apply
5.1 7.2, 7.3
7 7.3
9 10.1

WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the

scope of the standard."
---------------------- Page: 6 ----------------------
SIST EN ISO 11138-2:2009
INTERNATIONAL ISO
STANDARD 11138-2
Second edition
2006-07-01
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 11138-2:2006(E)
ISO 2006
---------------------- Page: 7 ----------------------
SIST EN ISO 11138-2:2009
ISO 11138-2:2006(E)
PDF disclaimer

This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but

shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In

downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat

accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation

parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In

the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

© ISO 2006

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11138-2:2009
ISO 11138-2:2006(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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 ri

...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2006)Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2006)Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:prEN ISO 11138-2kSIST prEN ISO 11138-2:2009en01-marec-2009kSIST prEN ISO 11138-2:2009SLOVENSKI

STANDARD
kSIST prEN ISO 11138-2:2009

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 11138-2December 2008ICS 11.080.01Will supersede EN ISO 11138-2:2006

English VersionSterilization of health care products - Biological indicators - Part2: Biological indicators for ethylene oxide sterilization processes(ISO 11138-2:2006)Stérilisation des produits de santé - Indicateurs biologiques- Partie 2: Indicateurs biologiques pour la stérilisation àl'oxyde d'éthylène (ISO 11138-2:2006)Sterilisation von Produkten für die Gesundheitsfürsorge -Biologische Indikatoren - Teil 2: Biologische Indikatoren fürSterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 102.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:

Avenue Marnix 17,

B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 11138-2:2008: EkSIST prEN ISO 11138-2:2009

prEN ISO 11138-2:2008 (E) 2 Contents Page Foreword ..............................................................................................................................................................3Annex ZA (informative)

Relationship between this
European
Standard and the Essential Requirements

of EU Directive 93/42/EEC ...........................................................................................4 kSIST prEN ISO 11138-2:2009

prEN ISO 11138-2:2008 (E) 3 Foreword The text of ISO 11138-2:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 11138-2:2008 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 11138-2:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 11138-2:2006 has been approved by CEN as a prEN ISO 11138-2:2008 without any modification. kSIST prEN ISO 11138-2:2009

prEN ISO 11138-2:2008 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements

of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA – Correspondence between
this European Standard and Directive 93/42/EEC on medical devices

WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the scope of the standard."

Clause(s)/sub-clause(s) of this EN

Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes4 5, 13 The requirements of ISO 11138-1 apply 5.1 7.2, 7.3

7 7.3
9 10.1
kSIST prEN ISO 11138-2:2009
Reference numberISO 11138-2:2006(E)© ISO 2006

INTERNATIONAL STANDARD ISO11138-2Second edition2006-07-01Sterilization 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 kSIST prEN ISO 11138-2:2009

ISO 11138-2:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.

+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2006 – All rights reserved
kSIST prEN ISO 11138-2:2009

ISO 11138-2:2006(E) © ISO 2006 – All rights reserved iiiForeword 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 11138-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11138-2:1994), which has been technically revised. ISO 11138 consists of the following parts, under the general title Sterilization of health care products — Biological indicators: ⎯ Part 1: General requ

...

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