EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01)

Dieser Teil von ISO 11137 legt Verfahren zur Ermittlung der Mindestdosis, die zur Erreichung einer festgelegten Anforderung an die Sterilität erforderlich ist, und Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erreichung eines Sterilitätssicherheitsniveaus, SAL von 10 6 fest. Dieser Teil von ISO 11137 legt auch Verfahren der Dosisüberprüfung zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest.
Dieser Teil von ISO 11137 definiert Produktfamilien für die Dosisfestlegung und Dosisüberprüfung.

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01)

L'ISO 11137-2:2006 spécifie des méthodes de détermination de la dose minimale nécessaire pour atteindre une exigence spécifiée de stérilité et des méthodes pour justifier l'utilisation de la dose stérilisante de 25 kGy ou de la dose stérilisante de 15 kGy, pour obtenir un niveau d'assurance de la stérilité, s, de 10-6. Elle spécifie aussi des méthodes d'audit de la dose pour démontrer l'efficacité continue de la dose stérilisante.
L'ISO 11137-2:2006 définit des familles de produits pour l'établissement de la dose et l'audit de la dose.

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2006, popravljena verzija 2006-08-01)

General Information

• Status: Withdrawn
• Publication Date: 29-May-2007
• Withdrawal Date: 14-Mar-2012
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.99 - Other standards related to sterilization and disinfection
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Mar-2012
• Completion Date: 15-Mar-2012
• 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/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 11137-2:2007 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

Relations

• Replaces: EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11137-2:2012 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
• Effective Date: 11-Apr-2012
• Corrected By: EN ISO 11137-2:2007/AC:2009 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009)
• Effective Date: 21-Jan-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11137-2:2007
01-september-2007
1DGRPHãþD
SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
SIST EN ISO 11137-2:2006
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO'RORþDQMHRGPHUND
VWHULOL]DFLMH,62SRSUDYOMHQDYHU]LMD
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose (ISO 11137-2:2006, corrected version 2006-08-01)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2007
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11137-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2007
ICS 11.080.01 Supersedes EN ISO 11137-2:2006
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2006, corrected
version 2006-08-01)
Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -
Établissement de la dose stérilisante (ISO 11137-2:2006, Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO
version corrigée 2006-08-01) 11137-2:2006, korrigierte fassung 2006-08-01)
This European Standard was approved by CEN on 12 May 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2007: E
worldwide for CEN national Members.

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EN ISO 11137-2:2007 (E)






Foreword



The text of ISO 11137-2:2006, corrected version 2006-08-01 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 11137-2:2007 by Technical
Committee CEN/TC 204 "Sterilization of medical devices", the secretariat of which is held by
BSI.

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 2007, and conflicting national
standards shall be withdrawn at the latest by May 2010.

This document supersedes EN ISO 11137-2:2006.

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 EU
Directive(s).

For relationship with EU Directive(s), 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 United
Kingdom.


Endorsement notice

The text of ISO 11137-2:2006, corrected version 2006-08-01 has been approved by CEN as EN
ISO 11137-2:2007 without any modifications.

2

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EN ISO 11137-2:2007 (E)

ANNEX ZA
(informative)

Relationship between this International Standard and the Essential
Requirements
...