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)

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• Status: Withdrawn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
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 29-Mar-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: 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)

Relations

• Replaces: EN ISO 11138-2:2006 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
• Effective Date: 08-Jun-2022
• Replaced By: 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)
• Effective Date: 13-May-2014

Standards Content (Sample)

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
...