ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.
Primarily intended for medical device manufacturers, the ISO standard promotes the safety of devices and equipment used for medical purposes. It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment. The standard was updated to better align with changes in medical device regulations around the world.
The ISO 14971 revision was aimed at clarifying the standard’s technical requirements by including more detailed information on the steps manufacturers must take to meet those requirements. It also includes new and updated terminology to reflect the current market needs. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel.
Peter Linders, Chair of the ISO technical committee that developed the documents, said it is a manufacturer’s responsibility to reduce the risks of medical devices. “ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place.”
ISO 14971 was developed jointly by technical committees ISO/TC 2101), Quality management and corresponding general aspects for medical devices, and IEC/TC 62, Electrical equipment in medical practice, of the International Electrotechnical Commission (IEC), with the active involvement of many regulators from around the world. It can be purchased from your national ISO member or through the ISO Store.
1) The secretariat for ISO/TC 210 is held by ANSI, ISO’s member for the USA.