Aktivní norma | Vydána: 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)

Dostupné jazyky: Anglicky

Dostupné provedení: Elektronické PDF, Tištěné

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Podrobné informace

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

Datum vydání: 12.08.2019

Stran: 26

Země: Mezinárodní technická norma

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Anotace

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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