Legislation/Applicable standard

ReferenceTitle
LVS EN ISO 10993-16:2009Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
LVS EN ISO 10993-17:2009Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
LVS EN ISO 10993-18:2009Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
LVS EN ISO 10993-3:2009Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
LVS EN ISO 10993-4:2009Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
LVS EN ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
LVS EN ISO 10993-6:2009Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
LVS EN ISO 10993-7:2009Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
LVS EN ISO 10993-9:2009Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
LVS EN ISO 11135-1:2007Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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