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SSH EN ISO 10993-10:2013

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 10: Prova për irritimin dhe ndjeshmërinë e lëkurës (ISO 10993-10:2010)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
30 mar 2015
95.99 Withdrawal of Standard   14 gush 2024

General information

95.99     14 gush 2024

DPS

DPS/KT 206

European Norm

11.100.20  

anglisht  

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Scope

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:

pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.

Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

Related directives

Directives related to this standards.

93/42/EEC

Pajisje Mjekësore

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 10993-10:2009

WITHDRAWN
SSH EN ISO 10993-10:2010

NOW

WITHDRAWN
SSH EN ISO 10993-10:2013
95.99 Withdrawal of Standard
14 gush 2024

REVISED BY

PUBLISHED
SSH EN ISO 10993-10:2023

Related project

Adopted from EN ISO 10993-10:2013