Designation:E1104−98(Reapproved2016)StandardSpecificationforClinicalThermometerProbeCoversandSheaths1ThisstandardisissuedunderthefixeddesignationE1104;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversallsingle-useclinicalther-mometerprobecoversandsheathsintendedforusewithanyclinicalthermometer.Requirementsaregivenforsafety,toxicity,handling,labeling,andphysicalintegrity.Testingproceduresforappropriaterequirementsandaglossaryoftermsusedwithinthestandardsareprovided.1.2Therequirementscontainedhereinareintendedtoensureadequateisolationofthepatientfromthetemperature-measuringdevice.Inaddition,thesafetyandhealthofthepatientshallnotbeadverselyaffected.Whenusedinaccor-dancewiththemanufacturer’sinstructions,theprobecover,sheath,andtemperaturemeasuringdeviceshallremitcorrecttemperaturereadingsasrequiredinSpecificationsE667andE1112.2.ReferencedDocuments2.1ASTMStandards:2E344TerminologyRelatingtoThermometryandHydrom-etryE667SpecificationforMercury-in-Glass,MaximumSelf-RegisteringClinicalThermometersE1112SpecificationforElectronicThermometerforInter-mittentDeterminationofPatientTemperature3.Terminology3.1Definitions—ThedefinitionsgiveninTerminologyE344shallapplytothisSpecificationwiththefollowingadditions:3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1measurementtime,n—timerequiredfromtimeofpatientcontacttothetimewhentheclinicalthermometermayberemovedorreadtowithinitsstatedaccuracyoftheclinicalthermometer.3.2.2patient,n—anyhumanwhosetemperatureisbeingtaken.3.2.3probe,n—anassemblyincludingthetransducerthatisusedtopositionthetransducerinthespecificlocationfromwhichthetemperatureistobedetermined.3.2.4probecoversandsheaths,n—devicesprovidedforthepurposeofpreventingbiologicalcontactbetweenthepatientandtheprobeorclinicalthermometer.3.2...
