Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Informácie o norme:

Označenie normy: ISO/IEC/GUIDE 63:2019-ed.3.0
Dátum vydania normy: 12.8.2019
Počet strán: 26
Približná hmotnosť: 78 g (0.17 libier)
Krajina: Medzinárodná technická norma
Kategória: Technické normy ISO

Anotácia textu normy ISO/IEC/GUIDE 63:2019-ed.3.0 :

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.