JIS T 14971:2003 English Edition

Medical devices - Application of risk management to medical devices

Abstract

This Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devcices and their accessories, including in vitro diagnostic medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control. The requirements of this International Standard are applicable to all stages of the life cycle of a medical device. This Standard does not apply to clinical judgements relating to the use of a medical device. It does not specify acceptable risk levels. This Standard does not require that the manufacturer has a formal quality system in place. However, risk management can be an integral part of a quality system.

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