nsBAS EN ISO 10993-18/A1:2024

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

General information

Status:Project

Number of pages:14

Adoption method:Proglašavanje

Language:engleski

Edition:1.

Realization date:28.03.2024

Forseen date for next stage code:27.05.2024

Technical committee:BAS/TC 25, Healthcare

Directives:

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

ICS:

11.100.20, Biological evaluation of medical devices

Abstract

Lifecycle

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Original document and degree of correspondence

EN ISO 10993-18:2020/A1:2023, identical

ISO 10993-18:2020/Amd 1:2022, identical

Work material

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