DPS
Drejtoria e Përgjithshme e Standardizimit
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 10993-10:2023

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

Aug 14, 2024

General information

60.60     Aug 14, 2024

DPS

DPS/KT 206

European Norm

11.100.20  

English  

Buying

Published

Language in which you want to receive the document.

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

Directives related to this standards.

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

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 10993-10:2013

NOW

PUBLISHED
SSH EN ISO 10993-10:2023
60.60 Standard published
Aug 14, 2024

Related project

Adopted from EN ISO 10993-10:2023 IDENTICAL