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BSI BS EN ISO 10993-10:2010

Biological evaluation of medical devices -- Tests for skin sensitization
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BSI BS EN ISO 10993-10:2010

Biological evaluation of medical devices -- Tests for skin sensitization

PUBLISH DATE 2012
PAGES 76
BSI BS EN ISO 10993-10:2010

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:

  1. pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;

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

  3. 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.

SDO BSI: British Standards Institution
Document Number ISO 10993-10
Publication Date April 30, 2012
Language en - English
Page Count 76
Revision Level
Supercedes
Committee CH/194
Publish Date Document Id Type View
Feb. 8, 2023 BS EN ISO 10993-10:2023 Revision
Feb. 28, 2014 BS EN ISO 10993-10:2013 Revision
Oct. 31, 2010 BS EN ISO 10993-10:2010 Revision
Feb. 28, 2010 BS EN ISO 10993-10:2009 Revision
May 15, 1996 BS EN ISO 10993-10:1996 Revision
April 30, 2012 BS EN ISO 10993-10:2010 Consolidated
Sept. 29, 2006 BS EN ISO 10993-10:2002 Consolidated