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ANSI/AAMI/ISO 14971-2000

Medical Devices - Risk Management - Part 1: Application of Risk Analysis to Medical Devices (revision and redesignation of ANSI/AAMI/ISO/IEC 14971-1-1998)

Specifies a procedure for the manufacturer to identify the hazards associated with medical devices and their accessories, including in vitro diagnostic devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.

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Association for the Advancement of Medical Instrumentation [aami]

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