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Designation:E1104−98(Reapproved2009)StandardSpecificationforClinicalThermometerProbeCoversandSheaths1ThisstandardisissuedunderthefixeddesignationE1104;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversallsingle-useclinicalther-mometerprobecoversandsheathsintendedforusewithanyclinicalthermometer.Requirementsaregivenforsafety,toxicity,handling,labeling,andphysicalintegrity.Testingproceduresforappropriaterequirementsandaglossaryoftermsusedwithinthestandardsareprovided.1.2Therequirementscontainedhereinareintendedtoensureadequateisolationofthepatientfromthetemperature-measuringdevice.Inaddition,thesafetyandhealthofthepatientshallnotbeadverselyaffected.Whenusedinaccor-dancewiththemanufacturersinstructions,theprobecover,sheath,andtemperaturemeasuringdeviceshallremitcorrecttemperaturereadingsasrequiredinSpecificationsE667andE1112.2.ReferencedDocuments2.1ASTMStandards:2E344TerminologyRelatingtoThermometryandHydrom-etryE667SpecificationforMercury-in-Glass,MaximumSelf-RegisteringClinicalThermometersE1112SpecificationforElectronicThermometerforInter-mittentDeterminationofPatientTemperature3.Terminology3.1Definitions—ThedefinitionsgiveninTerminologyE344shallapplytothisSpecificationwiththefollowingadditions:3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1measurementtime,n—timerequiredfromtimeofpatientcontacttothetimewhentheclinicalthermometermayberemovedorreadtowithinthestatedaccuracyoftheclinicalthermometer.3.2.2patient,n—anyhumanwhosetemperatureisbeingtaken.3.2.3probe,n—anassemblyincludingthetransducerthatisusedtopositionthetransducerinthespecificlocationfromwhichthetemperatureistobedetermined.3.2.4probecoversandsheaths,n—devicesprovidedforthepurposeofpreventingbiologicalcontactbetweenthepatientandtheprobeorclinicalthermometer.3.2.5suitablepackagingunit,n—theunit(s)ofpackagingforwhichaspecificrequirementofmarkingandlabelingislogicallyapplicable.Itshallnotbelessthanthesmallestunitintendedforsalebythemanufacturerordistributortothefinaluser.4.Requirements4.1General—Clinicalthermometerprobecoversandsheathsrepresentedascomplyingwiththisspecificationshallmeetalloftherequirementsspecifiedherein.4.2ProductSafety—Sheathsandprobecoversshallbeconstructedtoprecludesharppointsandedgesthatcouldcausepatientinjury.Probecoversandsheathsshallbeconstructedinsuchawaythatthepersonusingthemcaninstallandremovethemwithouttouchingthatportionoftheprobecoverorsheaththatcomesincontactwiththepatient.4.3PhysicalIntegrity—Theclinicalthermometerprobecoversandsheathsshallbeconstructedandpackagedsothatthephysicalintegrityoftheprobecoversandsheathswillbemaintainedwhenappliedto,used,andremovedfromatemperature-takingdeviceasprescribedbythemanufacturer(see5.3).4.4Toxicity—Whentheprobecoversorsheathsareusedasspecifiedbythemanufacturers,itspartsintendedforcontactwithanatomicalsitesduringpatientuseshallbenontoxic(see5.1).4.5Compatibility—Theclinicalthermometerprobecoversandsheathsshallbecompatiblewiththeintendeduseofthetemperature-takingdevice(see5.4.1).4.6Labeling:4.6.1Instructionsshallbeprovidedforproperusageofclinicalthermometerprobecoversorsheaths.1ThisspecificationisunderthejurisdictionofASTMCommitteeF04onMedicalandSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommitteeF04.33onMedical/SurgicalInstruments.CurrenteditionapprovedMay1,2009.PublishedJune2009.Originallyapprovedin1986.Lastpreviouseditionapprovedin2003asE1104–1998(2003).DOI:10.1520/E1104-98R09.2ForreferencedASTMstandards,visittheASTMwebsite,@astm.org.ForAnnualBookofASTMStandardsvolumeinformation,refertothestandard’sDocumentSummarypageontheASTMwebsite.Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959.UnitedStates1CopyrightbyASTMInt'l(allrightsreserved);4.6.2Suitablepackagingunitsofthethermometersheathsorprobecoversshallbearinlegiblecharactersadesignation(eitheraserialnumberoracode)toindicatethespecificmanufacturinglotinadditiontoallotherapplicablelabeling.Suitablepackagingunitsandotherlabelingshallalsobearastatementthatthethermometerprobecoversorsheathsareintendedforsingleuseonly.4.6.3Thetemperature-takingdeviceforwhichtheclinicalthermometerprobecoverorsheathisorisnotintendedshallbespecified.4.6.4Ifthetemperature-takingdevice’sperformanceandoperatingcharacteristics,suchasmeasurementtimeoraccuracy,areadverselyaffectedbytheprobecoverorsheath,theconsequencetothedevice’sperformancecharacteristicsmustbespecified(see5.4).4.6.5Probecoversandsheathsmayfailtoisolatethepatientfromthetemperaturemeasuringdeviceshallcontainacautionstatement.Susceptibilitytofailureofprobecoversorsheathsshallbedeterminedbyappropriatetestingbyeachmanufac-turerordistributor.4.6.6Identification:4.6.6.1Inorderthatpurchasersmayidentifyproductscon-formingtoallrequirementsofthisspecification,producersanddistributorsmayincl
本文标题:ASTM-E1104
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