I.S. EN 1441:1998

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

Defines a method for investigation by the manufacturer of the safety of a medical device, including in vitro diagnostic devices or accessories, by identification of hazards and estimation of the risks associated with the device. Particularly helpful in areas where relevant standards are unavailable or unused. Does not define levels of acceptability, or give detailed guidance on management of risks. Nor does it cover decision-making processes regarding assessing the indications and contra-indications for using a particular device.