EN ISO 11137-2:2015/A1:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

2022-06-21 - lack of compliance - publication on hold

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis - Änderung 1 (ISO 11137-2:2013/Amd 1:2022)

No scope available

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante - Amendement 1 (ISO 11137-2:2013/Amd 1:2022)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/Amd 1:2022)

General Information

• Status: Published
• Publication Date: 18-Apr-2023
• Withdrawal Date: 31-Jan-2023
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Apr-2023
• Completion Date: 19-Apr-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• 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/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/571 - COMMISSION IMPLEMENTING DECISION of 19.11.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards personal protective equipment in support of Regulation (EU) 2016/425 of the European Parliament and of the Council
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• 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 11137-2:2015/A1:2023 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

Relations

• Amends: EN ISO 11137-2:2015 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
• Effective Date: 30-Sep-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11137-2:2015/A1:2023
01-september-2023
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka
sterilizacije - Dopolnilo A1 (ISO 11137-2:2013/Amd 1:2022)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis - Änderung 1 (ISO 11137-2:2013/Amd 1:2022)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante - Amendement 1 (ISO 11137-2:2013/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2015/A1:2023
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2015/A1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11137-2:2015/A1:2023

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SIST EN ISO 11137-2:2015/A1:2023


EN ISO 11137-2:2015/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2023
EUROPÄISCHE NORM
ICS 11.080.01
English Version

Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose - Amendment 1 (ISO
11137-2:2013/Amd 1:2022)
Stérilisation des produits de santé - Irradiation - Partie Sterilisation von Produkten für die
2: Établissement de la dose stérilisante - Amendement Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der
1 (ISO 11137-2:2013/Amd 1:2022) Sterilisationsdosis - Änderung 1 (ISO 11137-
2:2013/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 11137-2:2015; it was approved by CEN on 29 May 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2015/A1:2023 E
worldwide for CEN national Members.

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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 7

2

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SIST EN ISO 11137-2:2015/A1:2023
EN ISO 11137-2:2015/A1:2023 (E)
European foreword
This document (EN ISO 11137-2:2015/A1:2023) 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 Amendment to the European Standard EN ISO 11137-2:2015 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by October 2023,
and conflicting national standards shall be withdrawn at the latest by October 2023.
Attention is drawn to the possibility that some
...