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SSH EN ISO 11607-1:2020/A11:2022

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

Aug 14, 2024

General information

60.60     Aug 14, 2024

DPS

DPS/KT 206

European Norm

11.080.30  

English  

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Related directives

Directives related to this standards.

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
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

Life cycle

NOW

PUBLISHED
SSH EN ISO 11607-1:2020/A11:2022
60.60 Standard published
Aug 14, 2024

Related project

Adopted from EN ISO 11607-1:2020/A1:2023