AAMI 14971
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Risk management- Part 1: Application of risk management
Association for the Advancement of Medical Instrumentation , 10/16/2000
Pages: 41
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.
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