ASTMF3738-25《使用第三體粒子在不利條件下對(duì)金屬-聚乙烯關(guān)節(jié)進(jìn)行關(guān)節(jié)模擬器磨損測(cè)試的標(biāo)準(zhǔn)測(cè)試方法》標(biāo)準(zhǔn)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
關(guān)節(jié)假體置換術(shù)是用于治療嚴(yán)重關(guān)節(jié)創(chuàng)傷或疾病的常用有效方式，隨著我國(guó)人口老齡化加劇及年輕群體關(guān)節(jié)需要（劇烈運(yùn)動(dòng)、交通事故等原因?qū)е麦y關(guān)節(jié)損傷），關(guān)節(jié)假體需要植入人體數(shù)十年，并保持其安全有效性才能為患者減輕身心負(fù)擔(dān)。（剩余4725字）