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  • ISO/TR 80002-2:2017

    Current The latest, up-to-date edition.

    Medical device software — Part 2: Validation of software for medical device quality systems

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  13-06-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

    ISO/TR 80002-2:2017 applies to

    - software used in the quality management system,

    - software used in production and service provision, and

    - software used for the monitoring and measurement of requirements.

    It does not apply to

    - software used as a component, part or accessory of a medical device, or

    - software that is itself a medical device.

    General Product Information - (Show below) - (Hide below)

    Document Type Technical Report
    Product Note THIS STANDARD ALSO REFERS TO ISO 12207
    Publisher International Organization for Standardization
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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