EN ISO 10993-10:2013

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) EN ISO 10993-10:2013

Publication date:   Nov 20, 2013

General information

99.60 Withdrawal effective   Feb 8, 2023

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 10993-10:2010

NOW

WITHDRAWN
EN ISO 10993-10:2013
99.60 Withdrawal effective
Feb 8, 2023

REVISED BY

PUBLISHED
EN ISO 10993-10:2023

Relations

Adopted from ISO 10993-10:2010 IDENTICAL