ISO/TR 24971:2013,Medical devices — Guidance on the application of ISO 14971.
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ISO/TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This 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.
Experience indicates that manufacturers have difficulty with practical implementation of some clauses of the risk management International Standard, ISO 14971: 2007, Medical devices- Application of risk management to medical devices. This Technical Report provides guidance to assist in the development,implementation and maintenance of risk management for medical devices that aim to meet the requirements of ISO 14971. It provides guidance for specific aspects of ISO 14971 for a wide varietyof medical devices. These medical devices include active, non-active, implantable, and non-implantable medical devices and in vitro diagnostic medical devices.