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ISO 10993-10:2010

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Pages: 74
Publication date: 2010-08-01
Price: 209 vnd

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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.
Document identifier
ISO 10993-10:2010
Title
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO Category
TC 194: Biological evaluation of medical devices
Publication date
2010-08-01
Status
Effective
International Relationship
AAMI/ISO 10993-10:2010/(R)2014 * DIN EN ISO 10993-10 * DIN EN ISO 10993-10 * BS EN ISO 10993-10:2010 * BS EN ISO 10993-10:2013
Cross references
Latest version
ISO 10993-10:2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Document identifier ISO 10993-10:2010
Publication date 2010-08-01
Classification 11.100. Laboratory medicine
11.100.20. Biological evaluation of medical devices, Medical microbiology, see 07.100.10
Status Effective
*
History of version
ISO 10993-10:2010 * ISO 10993-10:2002
Keywords
Classification
11.100. Laboratory medicine
11.100.20. Biological evaluation of medical devices, Medical microbiology, see 07.100.10
Pages
74
Price 209 vnd

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