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

Publication date:   Nov 15, 2023

General information

60.60 Standard published   Jul 26, 2023

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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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

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 10993-18:2020

NOW

PUBLISHED
EN ISO 10993-18:2020/A1:2023
60.60 Standard published
Jul 26, 2023