ISO/TS 10974《患者携带有源植入物接受磁共振成像的安全评估规范》第二版与第一版的比较研究

ISO/TS 10974是国际通用的有源植入式医疗器械磁共振成像安全评估技术规范,2018年发布的ISO/TS 10974第二版对第一版进行了大量修订。为了准确把握第二版技术内容,梳理了ISO/TS 10974第二版相比于第一版的主要变化,分析了第二版的技术进步,针对第二版中仍存在的问题进行了探讨。研究发现,ISO/TS 10974第二版在潜在患者危害分类及总体测试思路上与第一版保持一致,在射频致热、梯度致器械故障、复合场测试等项目的测试方法上有较大的调整与改进。但是,该技术规范依然需要扩大适用范围和引进新的研究成果,从而适应医疗器械行业的快速发展,起到更好的指导规范作用。

Comparison Study between the Second and First Editions of ISO/TS 10974-Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device

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.