2026 Volume 28 Issue 1 Pages 1-7
In recent years, as artificial intelligence (AI)-embedded medical devices become more common, the development of international standards has progressed. In response to this trend, we investigated the overviews of the 31 standards published by ISO/IEC JTC 1/SC 42 as of December 6, 2024. We then extracted 19 standards which are potentially relevant to the development of AI-embedded medical devices, based on their involvement in the product realization process.
Focusing on ISO/IEC 42001:2023 AI Management Systems from these 19 standards, we examined its differences from ISO 9001:2015 Quality Management Systems to clarify the characteristics of AI-related standards. As a result, a feature of ISO/IEC 42001:2023 is its identification of AI-specific risk sources.
Furthermore, it became clear that these risk sources are not limited to those related to patient safety as defined by ISO 13485:2016, but also include organizational risks as defined by ISO 9001:2015. Additionally, ISO/IEC 42001:2023 includes considerations for assessing risks related to the environment, human rights, and other areas, highlighting the significant impact AI has on society and industry. Based on these findings, it was concluded that when developing AI-embedded medical devices, requirements for operating the management system should be selected that consider not only patient safety risks but also organizational risks and related considerations.
Thus, by adopting requirements selected based on AI-specific risk sources, effective management of AI-embedded medical devices, which cannot be fully addressed by ISO 13485:2016 alone, can be achieved.
