ISO/TS 13004:2013
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Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
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IEC 80001-1:2010
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Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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IEC TR 80002-1:2009
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Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
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ISO/TR 24971:2013
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Medical devices Guidance on the application of ISO 14971
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ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
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EN 13612:2002/AC:2002
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PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
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IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
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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/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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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/TS 19218-1:2011
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Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
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ISO/IEC Guide 63:2012
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Guide to the development and inclusion of safety aspects in International Standards for medical devices
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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards
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IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes
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ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment
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IEC TR 60878:2015
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Graphical symbols for electrical equipment in medical practice
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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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ASTM F 2761 : 2009 : R2013
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Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
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IEC 62471:2006
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Photobiological safety of lamps and lamp systems
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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 14161:2009
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Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
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IEC TR 80001-2-1:2012
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Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
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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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IEC 60601-1-9:2007+AMD1:2013 CSV
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Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
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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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