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ISO 10993-10:2002

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

standard by International Organization for Standardization , 09/01/2002

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About This Item

 

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 delayed-type hypersensitivity.

This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.

Guidance is given in annex A for the preparation of materials specifically in relation to the above tests.

Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B.

Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.

 

Product Details

Published:
09/01/2002
Number of Pages:
49
File Size:
1 file , 430 KB
Note:
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


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

    • Historical Version

  3. ISO 10993-10:2002

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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 10993-10/Amd1:2006


    Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization - Amendment 1