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About This Item

 

Full Description

ISO/IEC Guide 63:2019 provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.

This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.

In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.

 

Document History

  1. ISO/IEC Guide 63:2019

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    Guide to the development and inclusion of aspects of safety in International Standards for medical devices

    • Most Recent
  2. ISO/IEC Guide 63:2012


    Guide to the development and inclusion of safety aspects in International Standards for medical devices

    • Historical Version
  3. ISO/IEC Guide 63:1999


    Guide to the development and inclusion of safety aspects in International Standards for medical devices

    • Historical Version