Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Terms and definitions<br>3 General requirements for risk management<br>4 Risk analysis<br>5 Risk evaluation<br>6 Risk control<br>7 Evaluation of overall residual risk acceptability<br>8 Risk management report<br>9 Production and post-production information<br>Annex A (informative) - Rationale for requirements<br>Annex B (informative) - Overview of the risk management process<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for medical devices<br>Annex C (informative) - Questions that can be used to identify<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;medical device characteristics that could impact on safety<br>Annex D (informative) - Risk concepts applied to medical devices<br>Annex E (informative) - Examples of hazards, foreseeable sequences<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of events and hazardous situations<br>Annex F (informative) - Risk management plan<br>Annex G (informative) - Information on risk management techniques<br>Annex H (informative) - Guidance on risk management for in vitro<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;diagnostic medical devices<br>Annex I (informative) - Guidance on risk analysis process for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;biological hazards<br>Annex J (informative) - Information for safety and information <br>about residual risk<br>Bibliography

Abstract

Describes 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
ProductNote	Reconfirmed F
Pages
ISBN