DS/ISO/IEC Guide 63:2012 ( Withdrawn )

Guide to the development and inclusion of safety aspects in International Standards for medical devices


Status:
Withdrawn
Type:
Standard
Language:
EN
Subject:
Price from:
€ 68.02

Scope

This Guide provides guidance to standard writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IECGuide 51 to include safety-related performance and usability.

Number of pages: 32

Published: 2012-03-09

Date of approval: 2012-02-17

Date of withdrawal: 2019-08-23

International relationships: ISO/IEC Guide 63:2012 IDT

ICS: 01.120 - Standardization. General rules 11.020 - Medical sciences in general

Item number: M252857


Committees

Committee

  • ISO/TC 210

Danish committee

DS/S-257