CEN Standards Collection 275/370: CEN TC 206-Biological Evaluation Of Medical Devices

complete:

EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)
EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
EN ISO 10993-7:2008/AC:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)


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EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

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EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)


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