ISO TR 24971

Description / Abstract: This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.

The guidance is intended to assist manufacturers and other users of the standard to:

— understand the role of international product safety and process standards in risk management;

— develop the policy for determining the criteria for risk acceptability;

— incorporate production and post-production feedback loop into risk management;

— differentiate between "information for safety" and "disclosure of residual risk"; and

— evaluate overall residual risk.