Designation:E1965−98(Reapproved2009)StandardSpecificationforInfraredThermometersforIntermittentDeterminationofPatientTemperature1ThisstandardisissuedunderthefixeddesignationE1965;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverselectronicinstrumentsin-tendedforintermittentmeasuringandmonitoringofpatienttemperaturesbymeansofdetectingtheintensityofthermalradiationbetweenthesubjectofmeasurementandthesensor.1.2Thespecificationaddressesassessingsubject’sbodyinternaltemperaturethroughmeasurementofthermalemissionfromtheearcanal.Performancerequirementsfornoncontacttemperaturemeasurementofskinarealsoprovided.1.3Thespecificationsetslimitsforlaboratoryaccuracyandrequiresdeterminationanddisclosureofclinicalaccuracyofthecoveredinstruments.1.4Performanceandstoragelimitsundervariousenviron-mentalconditions,requirementsforlabelingandtestproce-duresareestablished.NOTE1—ForelectricalsafetyconsultUnderwritersLaboratoryStan-dards.2NOTE2—ForelectromagneticemissionrequirementsandtestsrefertoCISPR11:1990ListsofMethodsofMeasurementofElectromagneticDisturbanceCharacteristicsofIndustrial,Scientific,andMedical(ISM)RadiofrequencyEquipment.31.5ThevaluesofquantitiesstatedinSIunitsaretoberegardedasthestandard.Thevaluesofquantitiesinparenthe-sesarenotinSIandareoptional.1.6Thefollowingprecautionarycaveatpertainsonlytothetestmethodportion,Section6,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimita-tionspriortouse.2.ReferencedDocuments2.1ASTMStandards:4E177PracticeforUseoftheTermsPrecisionandBiasinASTMTestMethodsE344TerminologyRelatingtoThermometryandHydrom-etryE667Spec...
