AAMI TIR19 : 1998
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GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
EN ISO 10993-2:2006
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Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) |
EN ISO 14155:2011/AC:2011
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
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) |
ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
ISO 14630:2012
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Non-active surgical implants General requirements |
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) |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements |
ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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) |
ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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 |
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 |
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) |
ISO 10993-6:2016
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Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
EN ISO 14630:2012
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Non-active surgical implants - General requirements (ISO 14630:2012) |