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MEDICAL DEVICES - RISK MANAGEMENT - APPLICATION OF RISK ANALYSIS TO MEDICAL DEVICES
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Available format(s): Hardcopy, PDF
Superseded date: 01-09-2001
Language(s): English
Published date:
Publisher: Canadian Standards Association
1 Scope2 Definitions3 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 report4 Review of risk analysisAnnexesA - Guidance on risk analysis procedure for in vitro diagnostic devicesB - Guidance on risk analysis procedure for toxicological hazardsC - Examples of possible hazards and contributing factors associated with medical devicesD - Information on risk analysis techniquesE - Simplified relationship between risk analysis and other risk management activitiesF - Bibliography
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.
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