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 / 中国医疗器械杂志

ABSTRACT

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.