DS/ISO/IEC Guide 63:2019

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


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Pris fra:
kr. 555,00

Beskrivelse

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.


Antal sider: 38

Udgivet: 2019-08-23

Godkendelsesdato: 2019-08-19

Internationale relationer : ISO/IEC Guide 63:2019 IDT

ICS: 01.120 - Standardisering. Generelle regler 11.040.01 - Medicinsk udstyr. Generelt

Varenummer: M294671


Udvalg og komiteer

Komite

  • ISO/TMBG