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ANSI/AAMI/ISO 10993-13:2010/(R)2019; Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices

  • Copyright year: 2020
  • Pages: 28
  • Publisher: AAMI
Abstract

Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

Keywords
biological evaluation, design, polymeric, degradation

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