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EVS-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)

General information
Valid from 15.08.2023
Base Documents
ISO 10993-18:2020/Amd 1:2022; EN ISO 10993-18:2020/A1:2023
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
15.08.2023
Amendment
15.08.2023
Main + amendment
15.06.2020
Main
The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN ISO 10993-18:2020/A1:2023 modifies the European standard EN ISO 10993-18:2020.

In this amendment, you can find the relationship between EN ISO 10993-18:2020 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.
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