This National Standard of Canada is equivalent to International Standard ISO 14971:2000. 1 Scope 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 requiremetns 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 judgements relating to
the use of a medical device. It does not specify acceptable risk levels. This International 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 (see, for example, Table G.1).