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EN ISO 11607-2:2020/A1:2023

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)

Publication date:   Feb 19, 2024

General information

60.60 Standard published   Oct 25, 2023

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.30   Sterilized packaging

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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

Harmonized/Supporting
Legislation 2017/745
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

Harmonized/Supporting
Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 11607-2:2020

NOW

PUBLISHED
EN ISO 11607-2:2020/A1:2023
60.60 Standard published
Oct 25, 2023