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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 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
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ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements |
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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 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
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ISO 11135-1:2007
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Sterilization 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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ISO 14630:2012
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Non-active surgical implants General requirements |
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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
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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 10993-1:2009
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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 14971-1:1998
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Medical devices Risk management Part 1: Application of risk analysis |
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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 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
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ISO 11137:1995
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Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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EN 980:2008
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Symbols for use in the labelling of medical devices |
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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 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |