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SRPS EN ISO 10993-10:2023

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Mar 30, 2023

General information

60.60     Mar 30, 2023

ISS

Z076

European Norm

11.100.20  

English  

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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 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
Directive 2017/745

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 10993-10:2014

NOW

PUBLISHED
SRPS EN ISO 10993-10:2023
60.60 Standard published
Mar 30, 2023

Related project

Adopted from EN ISO 10993-10:2023

Adopted from ISO 10993-10:2021