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 80601-2-69:2014
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Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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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 15223-2:2010
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Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
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EN 15986:2011
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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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ISO 15001:2010
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Anaesthetic and respiratory equipment Compatibility with oxygen
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IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
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IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to 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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ISO 80601-2-12:2011
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Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices
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ANSI Z79.16 : 1983
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CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE,
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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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ISO 80369-1:2010
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Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
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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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ISO/TR 11991:1995
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Guidance on airway management during laser surgery of upper airway
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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 7000:2014
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Graphical symbols for use on equipment Registered symbols
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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 4135:2001
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Anaesthetic and respiratory equipment Vocabulary
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ISO 10524-1:2006
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Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
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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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ISO 10524-2:2005
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Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
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ASTM F 640 : 2012 : REDLINE
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Standard Test Methods for Determining Radiopacity for Medical Use
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ISO 7396-1:2016
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Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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