BS EN ISO 14971:2012

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/EE
         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

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.

ISO 14971:2007 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.