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  • BSI
    PD ISO/IEC GUIDE 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
    Edition: 2019
    $442.60
    / user per year

Description of PD ISO/IEC GUIDE 63:2019 2019

This document 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.



Standard NumberPD ISO/IEC GUIDE 63:2019
TitleGuide to the development and inclusion of aspects of safety in International Standards for medical devices
StatusDefinitive
Publication Date2019-08-21
Identical National Standard OfISO/IEC GUIDE 63:2019
DescriptorsInternational standards, Risk assessment, Standards, Medical equipment, Safety
ICS01.120 Standardization. General rules, 11.040.01 Medical equipment in general
CommitteeCH/210/4
ISBN978 0 539 03709 8
PublisherBSI
Pages38

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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