DS/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in international standards for medical devices


Status:
Current
Type:
Standard
Language:
EN
Price from:
€ 74.41

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.


Number of pages: 38

Published: 2019-08-23

Date of approval: 2019-08-19

International relationships: ISO/IEC Guide 63:2019 IDT

ICS: 01.120 - Standardization. General rules 11.040.01 - Medical equipment in general

Item number: M294671


Committees

Committee

  • ISO/TMBG