Foreword
Introduction
1 Scope
2 Definitions
3 Procedure
    3.1 General
    3.2 Identification of qualitative and quantitative
          characteristics related to medical devices
    3.3 Identification of possible hazards
    3.4 Estimation of the risks for each hazard
    3.5 Acceptability of risk
    3.6 Risk reduction
    3.7 Generation of other hazards
    3.8 Evaluation of all identified hazards
    3.9 Risk analysis report
4 Review of risk analysis
Annexes
A (informative) Guidance on risk analysis procedure for
    in vitro diagnostic devices
B (informative) Guidance on risk analysis procedure for
    toxicological hazards
C (informative) Examples of possible hazards and
    contributing factors associated with medical devices
D (informative) Information on risk analysis techniques
E (Informative) Bibliography
ZA (informative) Clauses of this European Standard
    addressing essential requirements or other provisions
    of EU Directives