DSF/ISO/IEC DGuide 63 ( Forslag )

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


Status:
Forslag
Type:
Standard
Sprog:
EN

Beskrivelse

This sectorial Guide provides requirements and recommendations for the writers of medical device standards
6 for including aspects related to safety in those standards. These requirements and recommendations are
7 based on well-established risk management concepts and methodology. Therefore, it is applicable to any
8 aspect related to the safety of people, property, the environment, or to a combination of these.
9 In this guide, the term product includes a medical device or a system consisting of one or more medical
10 device(s) possibly combined with non-medical devices.

Antal sider: 34

Internationale relationer: ISO/IEC DGuide 63 IDT

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

Varenummer: M294671


Udvalg og komiteer

Komite

  • ISO/TMBG