GOST ISO 10993-13-2016
Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

Standard No.
GOST ISO 10993-13-2016
Release Date
2016
Published By
RU-GOST R
Latest
GOST ISO 10993-13-2016
Replace
GOST ISO 10993-13:2011

GOST ISO 10993-13-2016 Referenced Document

  • ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • ISO 3696:1987 Water for analytical laboratory use; Specification and test methods

GOST ISO 10993-13-2016 history

  • 2016 GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • 2011 GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices



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