Active standard | Published: 12/08/2019

ISO/IEC/GUIDE 63:2019-ed.3.0

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
(Guide pour l´élaboration des aspects de sécurité et leur incorporation dans des Normes internationales relatives aux dispositifs médicaux)

Available languages: English

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Detail information

Designation: ISO/IEC/GUIDE 63:2019-ed.3.0

Publication date: 12/08/2019

Pages: 26

Country: International technical standard

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Anotation

Description / Abstract: 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.

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