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SRPS EN ISO 11137-1:2016/A2:2020

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)

May 29, 2020

General information

60.60     May 29, 2020

ISS

Z076

European Norm

11.080.01     11.080.99  

English  

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Related directives

Directives related to this standard.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
98/79/EC

In vitro diagnostic medical devices

Harmonized
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
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

Life cycle

NOW

PUBLISHED
SRPS EN ISO 11137-1:2016/A2:2020
60.60 Standard published
May 29, 2020

REVISED BY

PROJECT
dnaSRPS EN ISO 11137-1:2020

Related project

Adopted from EN ISO 11137-1:2015/A2:2019

Adopted from ISO 11137-1:2006/Amd 2:2018