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ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Купи
Действащ
Обект и област на приложение
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.
Жизнен цикъл
ПРЕДИ ТОВА
ОТМЕНЕН
ISO/IEC Guide 63:2012
СЕГА
ДЕЙСТВАЩ
ISO/IEC Guide 63:2019
60.60
Публикуван стандарт
12.08.2019 г.