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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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149712019PDF
December 12, 2018
978-1-57020-718-1
PDF
49
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