CSA ISO 14971 : 2007 : R2017

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

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.