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prEN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2024)

Publication date:   Jan 11, 2024

General information

40.60 Close of voting   Mar 7, 2024

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

2017/745

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

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Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11135:2014

PUBLISHED
EN ISO 11135:2014/A1:2019

NOW

IN_DEVELOPMENT
prEN ISO 11135
40.60 Close of voting
Mar 7, 2024