Medical devices—Application of risk management to medical devices
PLEASE NOTE: This document, known as a Draft American Standard, is not considered a final standard and there may be slight editorial changes to the final publication. By ordering this draft, you’ll be among the first to receive the final standard, which is expected to be published this fall. When the final standard is published, AAMI will send a link to download it to those who have purchased ANSI/AAMI/ISO 14971.
SUMMARY: 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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