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ISO 10993-10:2010

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

standard by International Organization for Standardization , 08/01/2010

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Full Description

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.
 

Product Details

Published:
08/01/2010
Number of Pages:
74
File Size:
1 file , 390 KB
Same As:
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
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-10:2021


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

    • Most Recent

  2. ISO 10993-10:2010

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

    • Historical Version

  3. ISO 10993-10:2002


    Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

    • Historical Version