AAMI ISO 14971 : 2007 : R2010

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 14971:2007
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
Annexes
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

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.