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EN ISO 11137-1:2015/A2:2019

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

Publication date:   Mar 16, 2020

General information

60.60 Standard published   Nov 20, 2019

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
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

Harmonized/Supporting
Legislation 2017/745
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

Harmonized/Supporting
Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11137-1:2015

NOW

PUBLISHED
EN ISO 11137-1:2015/A2:2019
60.60 Standard published
Nov 20, 2019

REVISED BY

IN_DEVELOPMENT
prEN ISO 11137-1