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About This Item

 

Full Description

Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitvity, including pretest considerations, details of the test procedures, and key factors for the interpretation of the results.
 

Document History

  1. AS ISO 10993.10-2003

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

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  2. AS ISO 10993.10-2002


    Biological evaluation of medical devices - Tests for irritation and sensitization

    • Historical Version