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AAMI 14971

M00002795

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AAMI 14971 Risk management- Part 1: Application of risk management

standard by Association for the Advancement of Medical Instrumentation, 10/16/2000

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This American National Standard specifies a procedure by which a manufacturer can identify thehazards associated with medical devices and their accessories (including in vitro diagnosticmedical devices), estimate and evaluate the risks, control these risks, and monitor theeffectiveness of the control.