ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, is a companion document to the globally recognized risk management standard ISO 14971, Medical devices – Application of risk management to medical devices. The ISO standard, which was updated in December 2019, 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.
Providing detailed guidance on how to use the standard most effectively, the recently published technical report – ISO/TR 24971 – clarifies the requirements of the standard and contains recommendations and practical examples on how to achieve compliance with those requirements. It follows the same structure and the same clause numbering as ISO 14971:2019 to facilitate its use.
Intended for use by manufacturers of medical devices, both ISO 14971 and ISO/TR 24971 are designed to be read and applied together, providing information on how to identify the hazards associated with medical devices, and measure and manage related risks.
Both documents were developed jointly by technical committees ISO/TC 210 , 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. They can be purchased from your national ISO member or through the ISO Store.
- The secretariat for ISO/TC 210 is held by ANSI, ISO’s member for the USA.