PLUS 14971 (2nd ed. pub. 2007)

Preface

This is the second edition of PLUS 14971, The ISO 14971:2007 essentials - A practical handbook for implementing the ISO 14971 Standard for medical devices. It supersedes the previous edition published in 2003. 

The primary objective of this Handbook is to provide both novice and experienced risk management practitioners with a concise, user-friendly guide to understanding and implementing the requirements of ISO 14971:2007. 

Scope

This International Standard 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. 

The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. 

This International Standard does not apply to clinical decision making. 

This International Standard does not specify acceptable risk levels. 

This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.