Revision of ISO 14971 and ISO/TR 24971 is underway

Revision of ISO 14971 and ISO/TR 24971 is underway

Joint Working Group 1 between ISO/TC 210 and IEC/SC 62A is preparing the next editions of ISO 14971 Medical devices – Application of risk management to medical devices and its companion document ISO/TR 24971 Medical devices – Guidance on the application of ISO 14971.

Joint Working Group 1 between ISO/TC 210 and IEC/SC 62A is preparing the next editions of ISO 14971 Medical devices – Application of risk management to medical devices and its companion document ISO/TR 24971 Medical devices – Guidance on the application of ISO 14971. The systematic review of the standard revealed a need for better explanation of the requirements and more guidance on how to perform risk management. Therefore, the efforts focus on clarifying the normative requirements in the standard, particularly concerning clinical benefits, risk-benefit analyses and post-production information. The key concepts and approach to risk management will be maintained. The annexes of ISO 14971 will be updated with more elaborate guidance and transferred to ISO/TR 24971. Since ISO 14971 describes the process to manage all device-related risks, JWG1 will also address the risks related to data privacy and system security. Further, the relationship with IEC 62366-1 for usability engineering will be explained. Target for publication is 2019.