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

Detailinformationen

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

Ausgabedatum: 12.08.2019

Seiten: 26

Land: Internationale technische Norm

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Erhältlich auf www.technormen.de

Annotation

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.