CEI UNI EN ISO 14971 : 2013

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
Annex ZA (informative) - Relationship between this European
         Standard and Requirements of EU Directive 93/42/EEC
         on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and Requirements of EU Directive 90/385/EEC
         on Active Implantable Medical Devices
Annex ZC (informative) - Relationship between this European
         Standard and Requirements of EU Directive 98/79/EC
         on In Vitro Diagnostic Medical Devices

Defines 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.