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SSH EN ISO 10993-18:2020/A1:2023

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)

Mar 28, 2024

General information

60.60     Mar 28, 2024

DPS

DPS/KT 206

European Norm

11.100.20  

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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

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Directive 2017/745

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SSH EN ISO 10993-18:2020/A1:2023
60.60 Standard published
Mar 28, 2024

Related project

Adopted from EN ISO 10993-18:2020/A1:2023