Standard

DS/ISO/IEC Guide 63:2019

Vejledning i udarbejdelse og inkludering af sikkerhedsaspekter i internationale standarder for medicinsk udstyr

Status
Gældende Checkmark
Type
Standard
Varenummer
M294671
Udgivelsesdato
2019-08-23
Komite

ISO/TMBG

Internationale relationer
Tooltip
ISO/IEC Guide 63:2019 IDT
Antal sider
38

Scope

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.