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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
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
15.08.2023
Amendment
EVS-EN ISO 10993-18:2020/A1:2023
15.08.2023
Main + amendment
EVS-EN ISO 10993-18:2020+A1:2023
15.06.2020
Main
EVS-EN ISO 10993-18:2020
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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EVS-EN ISO 10993-18:2020

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English