Table of Contents

Foreword
Introduction
1 Scope
2 The role of international product safety and process
  standards in risk management
3 Developing the policy for determining the criteria
  for risk acceptability
4 Production and post-production feedback loop
5 Differentiation of information for safety and
  disclosure of residual risk
6 Evaluation of overall residual risk

Abstract

This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 210