ASTMF3738-25《使用第三体粒子在不利条件下对金属-聚乙烯关节进行关节模拟器磨损测试的标准测试方法》标准解析

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Interpretation of ASTM F3738-25，Standard Test Method for Hip Simulator Wear Testing ofMetal-on-Polyethylene ArticulationsUnder Adverse Conditions Using Third-Body Particles

FAN Sijie GU Nan* （Shanghai Institute ofMedical Device Testing）

Abstract：IWearanddebris （bonefragments，bonecement，metal，orceramics）generatedbythefrictionofartificialjointsin thebodycanleadtobone dissolutionandcauselooseningandfailureof the prosthesis，whichnotonlyimposesasignificant economic burden on patients but also brings secondary suffering or even life-threatening risks.Continuall conducting reliabilitystudiesonjoint prostheses and standardizingreliabilitytests forjointprosthesesareofsignificance for human health.OnJune24，2025，ASTMF3738-25wasreleasedontheofficialASTMwebsiteinthe U.S.This methodintroduces Al2O3particlesastribologicalparticlesfortestingbasedonjointweartests，flingthegapinweartribologicalparticlesfor standards ofjoint prostheses testsathomeandabroad.Thispaperanalyzes the main contents of thisstandard，aiming to play aregulatoryroleinthereliabilityresearchofmedicaldevicesandthepromotionof thisstandard，providingareferencefor industryworkers’understanding of this standard.

Keywords：medical device; reliability; joint prosthesis;hip joint; wear; debris;tribological particle

0 引言

关节假体置换术是用于治疗严重关节创伤或疾病的常用有效方式，随着我国人口老龄化加剧及年轻群体关节需要（剧烈运动、交通事故等原因导致髋关节损伤），关节假体需要植入人体数十年，并保持其安全有效性才能为患者减轻身心负担。（剩余4725字）