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Thread: ISO Collection 106/300:ISO/TC 210-Quality management and corresponding general

  1. #1

    ISO Collection 106/300:ISO/TC 210-Quality management and corresponding general

    full list:

    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
    ISO 14971:2007 Medical devices -- Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels* labelling and information to be supplied -- Part 1: General requirements
    ISO 15223-2:2010 Medical devices -- Symbols to be used with medical device labels* labelling* and information to be supplied -- Part 2: Symbol development* selection and validation
    ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
    ISO 16142-1:2016 Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ISO/TS 19218-1:2011 Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
    ISO/TS 19218-1:2011/Amd 1:2013 Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
    ISO/TS 19218-2:2012 Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
    ISO/TR 24971:2013 Medical devices -- Guidance on the application of ISO 14971
    IEC 62304:2006 Medical device software -- Software life cycle processes
    IEC 62304:2006/Amd 1:2015 Medical device software -- Software life cycle processes
    IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devices
    IEC 62366-1:2015/Cor 1:2016 Medical devices -- Part 1: Application of usability engineering to medical devices
    IEC/TR 62366-2:2016 Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices
    IEC/TR 80002-1:2009 Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
    IEC/TR 80002-3:2014 Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
    ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
    IEC 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications
    ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods


    missing is:

    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices


    links:

    [link Point to another website Only the registered members can access]
    or

    [link Point to another website Only the registered members can access]


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  3. #2

    Re: ISO Collection 106/300:ISO/TC 210-Quality management and corresponding general

    added missing one:

    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices


    added new one:

    IEC 80369-5:2016/Cor 1:2017 Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications


    sector complete

    [link Point to another website Only the registered members can access]


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  5. #3

    Re: ISO Collection 106/300:ISO/TC 210-Quality management and corresponding general

    update:

    BQ or missing:

    ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels* labelling and information to be supplied -- Part 1: General requirements
    IEC/TR 80002-1:2009 Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
    IEC 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications


    the missing is:

    ISO/TR 80002-2:2017 Medical device software -- Part 2: Validation of software for medical device quality systems

    [link Point to another website Only the registered members can access]


  6. #4

    Re: ISO Collection 106/300:ISO/TC 210-Quality management and corresponding general

    full list 11.12.2017.

    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
    ISO 14971:2007 Medical devices -- Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
    ISO 15223-2:2010 Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
    ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
    ISO 16142-1:2016 Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ISO 16142-2:2017 Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    ISO/TS 19218-1:2011 Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
    ISO/TS 19218-1:2011/Amd 1:2013 Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
    ISO/TS 19218-2:2012 Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
    ISO/TR 24971:2013 Medical devices -- Guidance on the application of ISO 14971
    IEC 62304:2006 Medical device software -- Software life cycle processes
    IEC 62304:2006/Amd 1:2015 Medical device software -- Software life cycle processes
    IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devices
    IEC 62366-1:2015/Cor 1:2016 Medical devices -- Part 1: Application of usability engineering to medical devices
    IEC/TR 62366-2:2016 Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices
    IEC/TR 80002-1:2009 Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
    ISO/TR 80002-2:2017 Medical device software -- Part 2: Validation of software for medical device quality systems
    IEC/TR 80002-3:2014 Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
    ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
    IEC 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications
    IEC 80369-5:2016/Cor 1:2017 Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications
    ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods


    complete

    [link Point to another website Only the registered members can access]


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