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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)

Aug 31, 2023

General information

60.60     Aug 31, 2023

ISS

Z076

European Norm

11.080.99     11.080.01  

English  

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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

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 11137-2:2016/A1:2023
60.60 Standard published
Aug 31, 2023

REVISED BY

PROJECT
prSRPS EN ISO 11137-2:2024

Related project

Adopted from EN ISO 11137-2:2015/A1:2023

Adopted from ISO 11137-2:2013/Amd 1:2022 IDENTICAL