Table of Contents

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Principles for preparing medical device safety
  standards
4 Risk-based framework for developing a medical
  device safety standard
5 Facilitating the implementation of ISO 14971
  though product or process standards
Annex A (informative) - Product and process safety
        standards
Annex B (informative) - Risk information
Bibliography

Abstract

This Guide provides guidance to standards 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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TMBG
Supersedes	ISO/IEC GUIDE 63 : 1999