CAN/CSA-ISO 14971-07 (R2017)

Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

standard by Canada National Standard/Canadian Standards - ISO , 05/01/2007

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Full Description

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.

Product Details

Published:: 05/01/2007
Number of Pages:: 100
File Size:: 1 file , 2.1 MB
Product Code(s):: 2418541, 2418548, 2418541