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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
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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
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ISO/IEC Guide 63:2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices- Historical Version
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ISO/IEC Guide 63:1999
Guide to the development and inclusion of safety aspects in International Standards for medical devices- Historical Version