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Withdrawn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.

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SIST EN ISO 11138-2:2009

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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.

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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

2

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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
...

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
...

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