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【英文标准名称】:StandardTestMethodforConductingCyclicPotentiodynamicPolarizationMeasurementstoDeterminetheCorrosionSusceptibilityofSmallImplantDevices
【原文标准名称】:进行循环动电位极化测量以测定小型植入装置的腐蚀敏感性的标准试验方法
【标准号】:ASTMF2129-2006
【标准状态】:现行
【国别】:
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:腐蚀;耐腐蚀性;腐蚀试验;敏感性测定;测量;外科植入物;灵敏性;试验方法
【英文主题词】:corrosion;cyclicpolarization;medicaldevicetesting;pittingpotential;protectionpotential;restpotential;
【摘要】:Corrosionofimplantablemedicaldevicescanhavedeleteriouseffectsonthedeviceperformanceormayresultinthereleaseofcorrosionproductswithharmfulbiologicalconsequences;therefore,itisimportanttodeterminethegeneralcorrosionbehavioraswellasthesusceptibilityofthedevicestolocalizedcorrosion.Theformingandfinishingstepsusedtocreateanimplantabledevicemayhavesignificanteffectsonthecorrosionresistanceofthematerialoutofwhichthedeviceisfabricated.Duringtheselectionprocessofamaterialforuseasanimplantabledevice,testingthecorrosionresistanceofthematerialisanessentialstep;however,itdoesnotnecessarilyprovidecriticaldataregardingdeviceperformance.Toaccommodatethewidevarietyofdeviceshapesandsizesencountered,avarietyofholdingdevicescanbeused.Notethatthemethodisintentionallydesignedtoreachconditionsthataresufficientlyseveretocausebreakdownanddeteriorationofthemedicaldevicesandthattheseconditionsmaynotbenecessarilyencounteredinvivo.Theresultsofthiscorrosiontestconductedinartificialphysiologicalelectrolytescanprovideusefuldataforcomparisonofdifferentdevicematerials,designs,ormanufacturingprocesses.However,notethatthistestmethoddoesnottakeintoaccounttheeffectsofcells,proteins,andsoforthonthecorrosionbehaviorinvivo.1.1Thistestmethodassessesthecorrosionsusceptibilityofsmall,metallic,implantmedicaldevices,orcomponentsthereof,usingcyclic(forwardandreverse)potentiodynamicpolarization.Examplesofdevicetypesthatmaybeevaluatedbythistestmethodinclude,butarenotlimitedto,vascularstents,ureteralstents(SpecificationF1828),filters,supportsegmentsofendovasculargrafts,cardiacoccluders,aneurysmorligationclips,staples,andsoforth.1.2Thistestmethodisusedtoassessadeviceinitsfinalformandfinish,asitwouldbeimplanted.Thesesmalldevicesshouldbetestedintheirentirety.Theupperlimitondevicesizeisdictatedbytheelectricalcurrentdeliverycapabilityofthetestapparatus(seeSection).Itisassumedthattestmethods,suchasReferenceTestMethodG5andTestMethodG61havebeenusedformaterialscreening.1.3Becauseofthevarietyofconfigurationsandsizesofimplants,thistestmethodprovidesavarietyofspecimenholderconfigurations.1.4Thistestmethodisintendedforuseonimplantabledevicesmadefrommetalswitharelativelyhighresistancetocorrosion.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:8P.;A4
【正文语种】:


【英文标准名称】:Rigidprotectivecoversforliveworkingona.c.installations(IEC61229:1993,modified);GermanversionEN61229:1995
【原文标准名称】:在交流设备上带电作业用刚性保护罩
【标准号】:DINEN61229-1997
【标准状态】:现行
【国别】:德国
【发布日期】:1997-01
【实施或试行日期】:1997-01-01
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:电气试验;安全措施;规范(验收);定义;试验;电气工程;特性;安全工程;材料;检验;防护服装;质量保证;保护覆盖层;电绝缘材料;封盖物;刚性;电气保护设备;样品试验;职业安全;设备;绝缘;电气安全
【英文主题词】:
【摘要】:
【中国标准分类号】:C66
【国际标准分类号】:13_260
【页数】:37P;A4
【正文语种】:德语