NEN EN ISO 14971 : 2007 + COR 2012

Foreword
Introduction
Introduction to amendment 1:2003
1 Scope
2 Terms and definitions
3 General requirements for risk management
   3.1 National or regional regulatory requirements
   3.2 Risk management process
   3.3 Management responsibilities
   3.4 Qualification of personnel
   3.5 Risk management plan
   3.6 Risk management file
4 Risk analysis (Steps 1, 2 and 3 of Figure 2)
   4.1 Risk analysis procedure
   4.2 Intended use/intended purpose and
       identification of characteristics related
       to the safety of the medical device (Step 1)
   4.3 Identification of known or foreseeable
       hazards (Step 2)
   4.4 Estimation of the risk(s) for each hazard
       (Step 3)
5 Risk evaluation (Step 4)
6 Risk control (Steps 5 to 10)
   6.1 Risk reduction
   6.2 Option analysis (Step 5)
   6.3 Implementation of risk control measure(s)
       (Step 6)
   6.4 Residual risk evaluation (Step 7)
   6.5 Risk/benefit analysis (Step 8)
   6.6 Other generated hazards (Step 9)
   6.7 Completeness of risk evaluation (Step 10)
7 Overall residual risk evaluation (Step 11)
8 Risk management report (Step 12)
9 Post-production information (Step 13)
Annex A (informative) Questions that can be used to
        identify medical device characteristics that
        could impact on safety
Annex B (informative) Guidance on risk analysis for
        in vitro diagnostic medical devices
Annex C (informative) Guidance on risk analysis
        procedure for toxicological hazards
Annex D (informative) Examples of possible hazards
        and contributing factors associated with
        medical devices
Annex E (informative) Risk concepts applied to medical
        devices
Annex F (informative) Information on risk analysis
        techniques
Annex G (informative) Other standards that contain
        information related to the elements of risk
        management described in this International
        Standard
Annex H (informative) Rationale for requirements
Bibliography

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.