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ANSI/AAMI/ISO 14971:2000 and 14971/A1:2003

Medical devices - Application of risk management to medical devices (and amendment)

This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical 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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