ISO 22442-1:2015
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

Standard No.
ISO 22442-1:2015
Release Date
2015
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 22442-1:2020
Latest
ISO 22442-1:2020

ISO 22442-1:2015 Referenced Document

  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*2018-08-01 Update
  • ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
  • ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
  • ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
  • ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

ISO 22442-1:2015 history

  • 2020 ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
  • 2015 ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
  • 2007 ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management



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