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DS/EN ISO 10993-10

2013 Edition, October 16, 2013

Complete Document

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



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SAME AS ISO 10993-10
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Product Details:

  • Revision: 2013 Edition, October 16, 2013
  • Published Date: October 16, 2013
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Dansk Standardiseringsrad (DS)
  • Page Count: 82
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

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 a) pretest considerations, b) details of the test procedures, and 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. Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.