EN ISO 11137-2:2013

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

2012-07-10 EMA: Draft for final vote received in ISO/CS (see 2012-07-10 notification in dataservice).
2012-07-03 GVN: MINOR REVISION - MINOR REVISION - MINOR REVISION - MINOR REVISION

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2013)

Im vorliegenden Teil von ISO 11137 werden Verfahren zur Ermittlung der Mindestdosis, die zur Erfüllung einer festgelegten Anforderung an die Sterilität erforderlich ist, sowie Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erzielung eines Sterilitätssicherheitsniveaus, SAL, von 10−6 festgelegt. Dieser Teil von ISO 11137 legt auch Überprüfungsverfahren für die Sterilisationsdosis zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest.
Dieser Teil von ISO 11137 definiert Produktfamilien für die Festlegung der Sterilisationsdosis und die Überprüfungen der Sterilisationsdosis.

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2013)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2013)

Ta del standarda ISO 11137 določa metode za določanje minimalnega odmerka, ki je potreben za doseganje določene zahteve glede sterilnosti, in metode za utemeljitev uporabe 25 kGy ali 15 kGy kot odmerka sterilizacije za doseganje ravni zagotavljanja sterilnosti (SAL) 10–6. Ta del standarda ISO 11137 določa tudi metode za revizijo odmerka sterilizacije, ki se uporabljajo za dokaz stalne učinkovitosti odmerka sterilizacije. Ta del standarda ISO 11137 določa skupine izdelkov za določanje odmerka sterilizacije in revizijo odmerka sterilizacije.

General Information

• Status: Withdrawn
• Publication Date: 04-Jun-2013
• Withdrawal Date: 09-Jun-2015
• 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
• Completion Date: 10-Jun-2015
• 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
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 11137-2:2013 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Relations

• Replaces: EN ISO 11137-2:2012 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 11137-2:2015 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
• Effective Date: 24-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11137-2:2013
01-september-2013
1DGRPHãþD
SIST EN ISO 11137-2:2012
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO'RORþDQMHRGPHUND
VWHULOL]DFLMH,62
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose (ISO 11137-2:2013)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis (ISO 11137-2:2013)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante (ISO 11137-2:2013)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2013
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11137-2:2013

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SIST EN ISO 11137-2:2013


EUROPEAN STANDARD
EN ISO 11137-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2013
ICS 11.080.01 Supersedes EN ISO 11137-2:2012
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2013)
Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -
Établissement de la dose stérilisante (ISO 11137-2:2013) Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO
11137-2:2013)
This European Standard was approved by CEN on 25 May 2013.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2013: E
worldwide for CEN national Members.

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SIST EN ISO 11137-2:2013
EN ISO 11137-2:2013 (E)
Contents
Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6


2

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SIST EN ISO 11137-2:2013
EN ISO 11137-2:2013 (E)
Foreword
This document (EN ISO 11137-2:2013) has been prepared by Technical Committee ISO/TC 198 "Sterilization
of health care products" in collaboration with 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 December 2013, and conflicting national standards shall be withdrawn
at the latest by December 2013.
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 11137-2:2012.
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
...