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  • CSA ISO 14971-1 : 1999

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL DEVICES - RISK MANAGEMENT - APPLICATION OF RISK ANALYSIS TO MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-09-2001

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

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    Table of Contents - (Show below) - (Hide below)

    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 Review of risks
        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 - Guidance on risk analysis procedure for in vitro
        diagnostic devices
    B - Guidance on risk analysis procedure for toxicological
        hazards
    C - Examples of possible hazards and contributing factors
        associated with medical devices
    D - Information on risk analysis techniques
    E - Simplified relationship between risk analysis and
        other risk management activities
    F - Bibliography

    Abstract - (Show below) - (Hide below)

    Gives a method for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
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