FprEN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024) FprEN ISO 11137-1

Publication date:   Dec 19, 2024

General information

50.60 Close of voting. Proof returned by secretariat   Feb 11, 2025

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.99   Other standards related to sterilization and disinfection

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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

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

PREVIOUSLY

PUBLISHED
EN ISO 11137-1:2015

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

NOW

IN_DEVELOPMENT
FprEN ISO 11137-1
50.60 Close of voting. Proof returned by secretariat
Feb 11, 2025