Table of Contents

Preface
Layout of this Handbook
Introduction
PLUS 14971 - The ISO 14971:2007 essentials - A practical
 handbook for implementing the ISO 14971 Standard for
 medical devices
Scope
General requirements for risk management
Risk analysis
Risk evaluation
Risk control
Evaluation of overall residual risk acceptability
Risk management report
Production and post-production information
Annexes
A - List of key Standards and documents
B - Glossary of key terms and definitions
C - Overview of risk management process for medical devices
D - List of annexes in ISO 14971:2007
E - Contacts

Abstract

Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN