prBAS EN ISO 11607-2/A1:2025
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management
General information
Status:Project
Number of pages:24
Adoption method:Proglašavanje
Language:engleski
Edition:1.
Realization date:22.10.2024
Forseen date for next stage code:12.03.2025
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:
11.080.30, Sterilized packaging
Abstract
Lifecycle
...
Original document and degree of correspondence
EN ISO 11607-2:2020/A1:2023, identical
ISO 11607-2:2019/Amd 1:2023, identical
Work material
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