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ISO 25539-2:2012
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Cardiovascular implants Endovascular devices Part 2: Vascular stents |
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EN 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 (ISO 14937:2009) |
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EN ISO 10993-5:2009
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
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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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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 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
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EN ISO 10993-11:2009
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
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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 10993-17:2009
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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EN 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 (ISO 10993-13:2010) |
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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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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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EN ISO 10993-10:2013
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
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EN ISO 10993-7 : 2008 COR 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |
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EN ISO 10993-4:2017
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
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ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
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CEN ISO/TS 17665-2:2009
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Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
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EN ISO 11135:2014
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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
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EN ISO 10993-3:2014
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
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ISO 14630:2012
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Non-active surgical implants General requirements |
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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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ISO 12417-1:2015
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Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
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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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EN ISO 10993-18:2009
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Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
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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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EN ISO 10993-12:2012
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
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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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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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EN ISO 10993-15:2009
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
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EN ISO 10993-14:2009
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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
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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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EN 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 (ISO 14160:2011) |
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EN ISO 14630:2012
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Non-active surgical implants - General requirements (ISO 14630:2012) |