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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 13408-7:2012
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Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
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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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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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EN ISO 13408-3:2011
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Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
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EN ISO 13408-4:2011
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Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
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EN ISO 13408-5:2011
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Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
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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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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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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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ISO 25424:2009
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Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
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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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EN ISO 25424:2011
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Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
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EN ISO 9001:2015
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Quality management systems - Requirements (ISO 9001:2015)
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ISO 20857:2010
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Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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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 9001:2015
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Quality management systems — Requirements
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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 13408-6:2011/A1:2013
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/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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EN ISO 20857:2013
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Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
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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 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)
|
|
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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