Résumé
ISO/TS 10974 is a general international technical specification (TS) which concentrates on the safety assessment of magnetic resonance imaging (MRI) for active implantable medical devices. ISO/TS 10974 Ed.2 was published in 2018 with substantial revision to Ed.1. To provide a guideline for adopting this recently revised TS in practice, this paper summarized the major changes and analyzed the technical improvements in Ed.2. Moreover, we also discussed current and emerging challenges to MRI safety evaluation remaining in Ed.2. The study revealed the consistency between these two editions with respect to classification of potential patient hazards and testing strategies, whereas Ed.2 has many methodological improvements over Ed.1 in testing methods for RF-induced heating, gradient-induced malfunction, and combined field testing, etc. However, it is still necessary to expand the scope of applicability and to adopt latest research findings into this TS to keep pace with the rapid developments in industry, making it a better guidance in the future.
Sujets)
Humains , Sécurité du matériel , Imagerie par résonance magnétique , Prothèses et implantsRésumé
Concerning on the safety risks caused by electromagnetic interference of patients implanted with high-risk active implantable medical devices in the environment of domestic MUs, this study evaluates and focuses on the requirements of electromagnetic compatibility in domestic and international standards for rail transit vehicles, the main mechanism of risks caused by EMI, the actual measurement of environmental data in MUs and the working performance of various active implantables in the compartment. The test results shows that all kinds of active implantable medical device samples works normally in the CRH2A EMU in China, and there is still a large margin between the measured radiation emission in MU and the limit required by the standards.