Title
Medical devices - Application of risk management to medical devices
Executive summary
Procedure for risk assessment of medical devices by manufacturers.
Abstract
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices 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. It provides a framework within which experience, insight and judgement are applied systematically to manage these risks.
This International Standard does not apply to clinical judgements relating to the use of a medical device. It does not specify acceptable risk levels.
Type
Specification
History and related standards
This International Standard supersedes BS EN 1441:1998 which is withdrawn.
