BAS EN ISO 11137-1/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
General Information
Status: Published
No. of pages: 16
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 30.09.2020
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
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;
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;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
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;
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;
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Abstract
Lifecycle
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Original document and degree of correspondence
- EN ISO 11137-1:2015/A2:2019, identical
- ISO 11137-1:2006/Amd 2:2018, identical