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 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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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 15223-2:2010
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Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
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EN ISO 10993-2:2006
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Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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EN ISO 14155:2011/AC:2011
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
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EN ISO 13408-1:2015
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Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
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EN ISO 10993-9:2009
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
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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 ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
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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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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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EN ISO 10993-6:2016
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
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EN ISO 11137-2:2015
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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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 11137-3:2017
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Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
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EN 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 (ISO 11135-1:2007)
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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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EN ISO 11137-1:2015
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
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EN ISO 14971:2012
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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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 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice
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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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EN 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 (ISO 17665-1:2006)
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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 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 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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EN 980:2008
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Symbols for use in the labelling 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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EN ISO 11137-3:2017
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Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
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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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EN ISO 14630:2012
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Non-active surgical implants - General requirements (ISO 14630:2012)
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