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prEN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023) prEN ISO 11137-1

Publication date:   Apr 13, 2023

General information

45.99 Dispatch of FV draft to CCMC   Nov 13, 2023

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.99   Other standards related to sterilization and disinfection

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Draft

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Related legislation

Legislation 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

Legislation 2017/745
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

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11137-1:2015

PUBLISHED
EN ISO 11137-1:2015/A2:2019

NOW

IN_DEVELOPMENT
prEN ISO 11137-1
45.99 Dispatch of FV draft to CCMC
Nov 13, 2023