新版外科植入物磁共振兼容性ASTM标准与YY/T 0987—2016系列标准差异的研究

Comparison Study on Differences between the Latest Edition of ASTM Standards and YY/T 0987—2016 Series Standards for Magnetic Resonance Compatibility of Surgical Implants

YY/T0987-2016系列标准转化于对应的ASTM(American Society of Testing Materials,美国材料实验协会)标准,规范了外科植入物磁共振兼容性相关标记与测试方法。随着科学认知的进步与技术发展,ASTM陆续对标准进行了修订。该文梳理了新版ASTM标准,分析了新版标准相较于YY/T0987-2016加入的技术进步内容、指出尚未解决的问题。研究发现,除图像伪影部分外,其余条目均有更新:比如,ASTMF2503医疗安全标记标准范围扩大至包含ISO标准,磁致位移力、射频致热与磁致扭矩试验方法均有较大调整与改进。国内标准应尽快跟进国际步伐,增添最新成熟研究成果,以更好地规范、指导、促进行业发展。

The series of YY/T 0987 standards converted from the corresponding ASTM(American Society for Testing and Materials)standards regulate the marking medical devices and testing methods for passive implants in the magnetic resonance environment.Along with the advancement of scientific cognition and the development of technology,the ASTM continuously amends and updates standards.This article studies the new version of ASTM standards and analyzes the advancing parts newly added as compared to the current YY/T 0987-2016 standard and eventually pinpoints some problems that remained to be solved.Except for the standard for image artifacts,this study found out that other standards had also been constantly updated,such as the standard of ASTM F2503 for marking medical devices extends its referenced documents and adds some ISO standards in,meanwhile,the test method on magnetically induced displacement force,radio frequency induced heating and magnetically induced torque also had been significantly adjusted and improved accordingly.This article recommends that domestic standards need to keep pace with the latest edition of ASTM F standards and to supplement new research achievements timely,just in order to provide a better normalization,guidance and support to the development of Chinese passive implants industry.