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SRPS EN ISO 11137-2:2016/A1:2023
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Buying
Published
Scope
Amendments are given in clauses 2 and 9.
Related directives
Directives related to this standard.
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
Life cycle
NOW
PUBLISHED
SRPS EN ISO 11137-2:2016/A1:2023
60.60
Standard published
Aug 31, 2023