Standard: AAMI 14971

MEDICAL DEVICES—APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

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Scope:

This International 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.

The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.

This International Standard does not apply to clinical decision making.

This International Standard does not specify acceptable risk levels.

This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 14971
Publish Date: 2007-01-01
Page Count: 100
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Standards That Reference This Standard

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