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SRPS 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)

Oct 31, 2023

General information

60.60     Oct 31, 2023

ISS

Z076

European Norm

11.100.20  

English  

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Scope

Changes are in 5.6; 6.2; 6.3; Table D.2; E.3; Bibliography.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Life cycle

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PUBLISHED
SRPS EN ISO 10993-18:2020/A1:2023
60.60 Standard published
Oct 31, 2023

Related project

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

Adopted from ISO 10993-18:2020/Amd 1:2022 IDENTICAL