Guide to the development and inclusion of aspects of safety in International Standards for medical devices
NORM herausgegeben am 12.8.2019
Bezeichnung normen: ISO/IEC/GUIDE 63:2019-ed.3.0
Ausgabedatum normen: 12.8.2019
Zahl der Seiten: 26
Gewicht ca.: 78 g (0.17 Pfund)
Land: Internationale technische Norm
Kategorie: Technische Normen ISO
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.