ISO 10993-15-2000 医疗器械的生物学评价第15部分:金属与合金降解产物的识别与定性

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part15:Identificationandquantificationofdegradationproductsfrommetalsandalloys
【原文标准名称】:医疗器械的生物学评价第15部分:金属与合金降解产物的识别与定性
【标准号】:ISO10993-15-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-12
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;识别;医疗产品;评定;合金;降解;测定;分解;生物试验;分解产物;毒理测定;量化;金属
【英文主题词】:Alloys;Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradation;Determination;Electrochemicalmethods;Evaluations;Guidebooks;Identification;Implants(surgical);Medicaldevices;Medicalproducts;Metals;Quantification;Reagents;Specimenpreparation;Testing;Toxicologicaltesting;Verification
【摘要】:ThispartofISO10993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmetallicmedicaldevicesorcorrespondingmaterialsamplesfinishedasreadyforclinicaluse.Itisapplicableonlytothosedegradationproductsgeneratedbychemicalalterationofthefinishedmetallicdeviceinaninvitroaccelerateddegradationtest.Becauseoftheacceleratednatureofthesetests,thetestresultsmaynotreflecttheimplantormaterialbehaviorinthebody.Thedescribedchemicalmethodologiesareameanstogeneratedegradationproductsforfurtherassessments.ThispartofISO10993isnotapplicabletodegradationproductsinducedbyappliedmechanicalstress.NOTEMechanicallyinduceddegradation,suchaswear,maybecoveredintheappropriateproduct-specificstandard.Whereproduct-groupstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(<10)containedinthespecificmetaloralloyisnotaddressedinthispartofISO10993,norarespecificrequirementsforacceptablelevelsofdegradationproductsprovidedinthispartofISO10993.ThispartofISO10993doesnotaddressthebiologicalactivityofthedegradationproducts;seeinsteadtheapplicableclausesofISO10993-1andISO10993-17.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:12P;A4
【正文语种】:英语