UNI EN ISO 14971 : 2008

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for risk management
  3.1 Risk management process
  3.2 Management responsibilities
  3.3 Qualification of personnel
  3.4 Risk management plan
  3.5 Risk management file
4 Risk analysis
  4.1 Risk analysis process
  4.2 Intended use and identification of characteristics related
       to the safety of the medical device
  4.3 Identification of hazards
  4.4 Estimation of the risk(s) for each hazardous situation
5 Risk evaluation
6 Risk control
  6.1 Risk reduction
  6.2 Risk control option analysis
  6.3 Implementation of risk control measure(s)
  6.4 Residual risk evaluation
  6.5 Risk/benefit analysis
  6.6 Risks arising from risk control measures
  6.7 Completeness of 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
Annex ZA (informative) - Relationship between this European Standard
         and the Essential Requirements of EU Directives 93/42/EEC
         Medical Devices, 90/385/EEC Active Implantable Medical
         Devices and 98/79/EC In Vitro Diagnostic Devices
Bibliography

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.