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SRPS EN ISO 11135:2015/A1:2020
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Buying
Published
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
Harmonized2017/746
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
HarmonizedLife cycle
NOW
PUBLISHED
SRPS EN ISO 11135:2015/A1:2020
60.60
Standard published
May 29, 2020
REVISED BY
PROJECT
naSRPS EN ISO 11135:2020