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ANSI/AAMI/ISO 14971:2019 (PDF)

Medical devices—Application of risk management to medical devices

SUMMARY: This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

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December 12, 2018
Available for Immediate Download