This standard 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. The requirements of this standard are applicable to all stages of the life-cycle of a medical device. This standard does not apply to clinical decision making. This standard does not specify acceptable risk levels. This 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.

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