ISO-10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO-10993-10 - 3RD EDITION - CURRENT
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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.

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

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Document Number

ISO 10993-10:2010

Revision Level

3RD EDITION

Status

Current

Publication Date

Aug. 1, 2010

Committee Number

ISO/TC 194