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EN ISO 11137-2:2015/A1:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

Publication date:   Aug 14, 2023

General information

60.60 Standard published   Apr 19, 2023

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

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
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

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11137-2:2015

NOW

PUBLISHED
EN ISO 11137-2:2015/A1:2023
60.60 Standard published
Apr 19, 2023

REVISED BY

IN_DEVELOPMENT
prEN ISO 11137-2 rev