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【英文标准名称】:StandardPracticeforDescribingSystemOutputofImplantableMiddleEarHearingDevices
【原文标准名称】:可植入中耳的听觉设备的描述系统输出的标准实施规程
【标准号】:ASTMF2504-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.37
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:耳;听力;中的;输出;系统输出
【英文主题词】:electromechanicalhearing;hearingimplant;IHD;implantablehearingaid;implantablemiddleearhearingdevice;IMEHD;laserinterferometry;middleear;middleearimplant;systemoutput;systemperformance;temporalbone;transferfunction;vibrational
【摘要】:IMEHDsarealternativestoairconductionhearingaids.Theyaresimilartoairconductionhearingaidsinthattheyprocessincomingsoundbyapplyingfrequencyshapingandcompressiontocreateananalog,vibratoryaudiofrequencyoutput.IMEHDsdifferfromhearingaidsinthattheydonotcreateanairborneacousticaloutputsignalwithanelectroacousticaloutputtransducerintheexternalearcanal,butratheramechanicalstimulationthatresultsinthevibrationofthecochlearfluid.Therefore,theIMEHDoutputsignalisnotreadilyaccessibleafterimplantationinthewayhearingaidoutputisaccessiblewithreal-earprobemicrophonemeasurements.Differentdeviceswillusedifferentmethodsofcouplingtotheossicularchainorcochlea.Thismakesitdifficulttodesignauniformmodelofthemiddleearinthewaythe2-cm3couplerisusedasamodeloftheexternalearcanalwithconventionalhearingaids.Thispracticeprovidesuniformityofdatacollectionpractices,thusallowingIMEHDinvitroperformancestobeevaluatedandreadilycompared.Onceclinicaldataareavailable,theperformancespecificationscanbeaugmentedwithcorrespondingtransferfunctionsorresultsfrommeasurementsinpatients.Thetemporalboneisawell-acceptedmodelthatrelatescloselytothebiomechanicsofthelivingmiddleear,whichisreadilyrelatabletohearinglevel.LaserDopplervibrometryprovidesaccuratevelocitymeasurementsintherangesrequiredforhumanhearing.1.1Thispracticedefinesmeansfordescribingsystemperformance(exvivo)and,inparticular,systemoutputofanimplantablemiddleearhearingdevice(IMEHD)bymeasuringaphysicalquantitythatisrelevanttotheinsertiongainandoutputleveloftheIMEHDwhenimplantedinthepatient.1.2Thispracticeissimilartoheadphonecalibrationonanartificialearinwhichthesoundpressurelevel(indecibelsoundpressurelevel(SPL))measuredintheartificialearcanbeconvertedtopatienthearinglevel(indecibelhearinglevel(HL))usingaknowntransferfunction,asdefinedbyANSI3.7.Thesemeasurementscanthenbeusedtopredictsystemparametersrelevantforpatientbenefitsuchasfunctionalgain,maximumoutput,andvariability.Measurementsdefinedinthispracticeshouldbeusefulforpatients,clinicians,manufacturers,investigators,andregulatoryagenciesinmakingcomparativeevaluationsofIMEHDs.1.3ThevaluesgiveninSIunitsaretobeconsideredthestandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35;C32
【国际标准分类号】:11_180_15
【页数】:6P.;A4
【正文语种】:


【英文标准名称】:Chemicalanalysisofammoniumnitratefortechnicaluse.Determinationofnitrateions.
【原文标准名称】:专业用硝酸铵的化学分析.硝酸盐离子的测定
【标准号】:NFT20-582-1965
【标准状态】:作废
【国别】:法国
【发布日期】:1965-10-01
【实施或试行日期】:1965-10-01
【发布单位】:法国标准化协会(FR-AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:化学分析;硝酸盐;硝酸铵;磺胺酸;α-萘胺;分光光度测量分析;亚硝酸盐;离子;化学分析和试验;铵无机化合物;含量测定;分光光度法;萘胺
【英文主题词】:
【摘要】:
【中国标准分类号】:G12
【国际标准分类号】:71_060_50
【页数】:2P.;A4
【正文语种】:其他