BS EN ISO 10993-15-2009 医疗器械的生物评定.第15部分:金属与合金降解产物的识别与量化(ISO10993-15-2000)

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part15:Identificationandquantificationofdegradationproductsfrommetalsandalloys(ISO10993-15:2000)
【原文标准名称】:医疗器械的生物评定.第15部分:金属与合金降解产物的识别与量化(ISO10993-15-2000)
【标准号】:BSENISO10993-15-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:合金;生物测定;生物试验;分解;分解产物;降解;测定;评估;识别;医疗器械;医疗产品;金属;量化;毒理测定
【英文主题词】:Alloys;Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Degradation;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Metals;Quantification;Toxicologicaltesting
【摘要】:ThispartofISO10993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmetallicmedicaldevicesorcorrespondingmaterialsamplesfinishedasreadyforclinicaluse.Itisapplicableonlytothosedegradationproductsgeneratedbychemicalalterationofthefinishedmetallicdeviceinaninvitroaccelerateddegradationtest.Becauseoftheacceleratednatureofthesetests,thetestresultsmaynotreflecttheimplantormaterialbehaviorinthebody.Thedescribedchemicalmethodologiesareameanstogeneratedegradationproductsforfurtherassessments.ThispartofISO10993isnotapplicabletodegradationproductsinducedbyappliedmechanicalstress.Whereproduct-groupstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(