BS EN ISO 10993-10:2013 PDF

Biological evaluation of medical devices - Tests for irritation and skin sensitization

First page of standard BS EN ISO 10993-10:2013

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Title (English):

BS EN ISO 10993-10:2013

Biological evaluation of medical devices - Tests for irritation and skin sensitization

Document status:: Withdrawn
Format:: Electronic (PDF)
Publication date:: February 28, 2014
ICS:: 11.100.20
Technical committee:: CEN
SKU:: BS EN ISO 10993-10:2013

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Abstract

1 Scope This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization . This part of ISO 10993 includes:

a) pretest considerations for irritation , including in silico and in vitro methods for dermal exposure;

b) details of in vivo ( irritation and sensitization) test procedures;

c) key factors for the interpretation of the results.

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

Related standards

Mentioned in the description and other BS standards

a) pretest considerations for irritation , including in silico and in vitro methods for dermal exposure;

b) details of in vivo ( irritation and sensitization) test procedures;

c) key factors for the interpretation of the results.

BS EN ISO 10993-10:2013 PDF

Abstract

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Abstract

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