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ISO 13408-4:2005
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Aseptic processing of health care products — Part 4: Clean-in-place technologies
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EN ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
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ISO 13408-7:2012
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Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
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ISO 10993-3:2014
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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ISO 10993-4:2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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ISO 10993-16:2017
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Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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ISO/TS 10993-20:2006
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Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
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ISO 14160:2011
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Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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ISO 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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ISO 13408-2:2003
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Aseptic processing of health care products Part 2: Filtration
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements
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ISO 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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ISO 13408-3:2006
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Aseptic processing of health care products Part 3: Lyophilization
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EN ISO 22442-3:2007
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Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
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ISO 10993-18:2005
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Biological evaluation of medical devices Part 18: Chemical characterization of materials
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ISO/TS 10993-19:2006
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Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
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ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
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ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements
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ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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ISO 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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ISO 10993-9:2009
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Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
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ISO 22442-3:2007
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Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 13408-6:2005
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Aseptic processing of health care products Part 6: Isolator systems
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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EN ISO 10993-1:2009/AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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ISO 10993-6:2016
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Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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ISO 13408-5:2006
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Aseptic processing of health care products Part 5: Sterilization in place
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