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ANSI/AAMI/ISO 14971:2007

Medical devices - Risk management - Application of risk management to medical devices

Specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. This standard does not specify acceptable risk levels.

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Association for the Advancement of Medical Instrumentation [aami]

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