摘要
Abstract
IWear and debris(bone fragments,bone cement,metal,or ceramics)generated by the friction of artificial joints in the body can lead to bone dissolution and cause loosening and failure of the prosthesis,which not only imposes a significant economic burden on patients but also brings secondary suffering or even life-threatening risks.Continually conducting reliability studies on joint prostheses and standardizing reliability tests for joint prostheses are of significance for human health.On June 24,2025,ASTM F3738-25 was released on the official ASTM website in the U.S.This method introduces Al2O3 particles as tribological particles for testing based on joint wear tests,filling the gap in wear tribological particles for standards of joint prostheses tests at home and abroad.This paper analyzes the main contents of this standard,aiming to play a regulatory role in the reliability research of medical devices and the promotion of this standard,providing a reference for industry workers'understanding of this standard.关键词
医疗器械/可靠性/关节假体/髋关节/磨损/磨屑/三体粒子Key words
medical device/reliability/joint prosthesis/hip joint/wear/debris/tribological particles
