nsBAS EN ISO 11137-2/A1:2024
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1
General information
Status:Project
Number of pages:14
Adoption method:Proglašavanje
Language:engleski
Edition:1.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
Directives:
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
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
ICS:
11.080.01, Sterilization and disinfection in general
11.080.99, Other standards related to sterilization and disinfection
11.080.99, Other standards related to sterilization and disinfection
Abstract
Lifecycle
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Original document and degree of correspondence
EN ISO 11137-2:2015/A1:2023, identical
ISO 11137-2:2013/Amd 1:2022, identical
Work material
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