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Norm

ISO 10993-10:2010

Issue date: 2010 07 27

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

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 s...
Withdrawn: 2021 11 16
Publisher:
International Organization for Standardization
Format:
Digital | 67 Pages
Language:
English

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.

ISO 10993-10:2021
2021 11 16
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Norm
ISO 10993-10:2010
2010 07 27
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Norm
ISO 10993-10:2002/Amd 1:2006
2006 07 06
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensi...
Norm
ISO 10993-10:2002
2002 09 26
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensi...
Norm
ISO 10993-10:1995
1995 03 09
Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization
Norm
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Norm
ISO 10993-10:2021
Issue date : 2021 11 16
Biological evaluation of medical devices — Part 10: Tests for skin sensitization