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

SIS-EN-ISO-10993-10 - 2013 EDITION - CURRENT
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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.

To find similar documents by classification:

11.100 (Laboratory medicine)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

Medical devices

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Designation Name

SS-EN ISO 10993-10:2013

Revision Level




Publication Date

Sept. 18, 2013



Page Count


International Equivalent

EN ISO 10993-10:2013(IDT); ISO 10993-10:2010(IDT)