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 10993-4:2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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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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ISO 8637:2010
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Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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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/TS 23810:2012
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Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup
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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 15675:2016
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Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
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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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ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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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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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 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 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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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 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
|