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.
10.3969/j.issn.1671-7104.2021.01.019
- Author:
Yonghua LI
1
;
Jing WANG
2
;
Weiqiang ZHANG
1
;
Sheng HU
1
Author Information
1. Shanghai Testing and Inspection Institution for Medical Devices, Shanghai, 201318.
2. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
ISO/TS 10974;
active implantable medical device;
magnetic resonance imaging
- MeSH:
Equipment Safety;
Humans;
Magnetic Resonance Imaging;
Prostheses and Implants
- From:
Chinese Journal of Medical Instrumentation
2021;45(1):90-95
- CountryChina
- Language:Chinese
-
Abstract:
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.
