【英文标准名称】:StandardPracticeforAssessingtheSolventResistanceofOrganicCoatingsUsingSolventRubs
【原文标准名称】:用溶剂擦除法评估有机覆层的耐溶性的标准实施方法
【标准号】:ASTMD5402-2006
【标准状态】:现行
【国别】:美国
【发布日期】:2006
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:ASTM
【标准类型】:()
【标准水平】:()
【中文主题词】:覆层;耐力;溶剂;表面处理;试验
【英文主题词】:Coatings;Resistance;Solvents;Surfacetreatment;Testing
【摘要】:
【中国标准分类号】:A29
【国际标准分类号】:25_220_60
【页数】:5P;A4
【正文语种】:英语


【英文标准名称】:Biologicalevaluationofmedicaldevices-Part15:Identificationandquantificationofdegradationproductsfrommetalsandalloys(ISO10993-15:2000);EnglishversionofDINENISO10993-15:2009-10
【原文标准名称】:医疗设备的生物评估.第15部分:金属与合金降解产物的识别与定性(ISO10993-15:2000,DINENISO10993-15:2009-10的英文版本)
【标准号】:DINENISO10993-15-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Alloys;Bioassay;Biologicalanalysisandtesting;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,maybecoveredintheappropriateproductspecificstandard.Whereproductgroupstandardsprovideapplicableproductspecificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshouldbeconsidered.Becauseofthewiderangeofmetallicmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedforquantifyingthedegradationproducts.Theidentificationoftraceelements(