EN ISO 10993-10:2023

Name: EN ISO 10993-10:2023
Brand: CEN
SKU: EN ISO 10993-10:2023
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Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021) EN ISO 10993-10:2023

Publication date: Jul 17, 2023

General information

Current stage: 60.60 Standard published Feb 8, 2023

Originator: CEN

Owner: CEN/TC 206 Biological and clinical evaluation of medical devices

Type: European Norm

ICS: 11.100.20 Biological evaluation of medical devices

Buying

Status: Published

Scope

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
—    details of in vivo skin sensitization test procedures;
—    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

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

PREVIOUSLY

WITHDRAWN
EN ISO 10993-10:2013

NOW

PUBLISHED
EN ISO 10993-10:2023
60.60 Standard published
Feb 8, 2023