Designation:E1299−96(Reapproved2010)StandardSpecificationforReusablePhase-Change-TypeFeverThermometerforIntermittentDeterminationofHumanTemperature1ThisstandardisissuedunderthefixeddesignationE1299;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversreusablephase-change-typeclinicalthermometers.1.2Thefollowingsafetyhazardscaveatpertainsonlytothetestmethodportion,Section6,ofthisspecification.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimita-tionspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E344TerminologyRelatingtoThermometryandHydrom-etryF895TestMethodforAgarDiffusionCellCultureScreeningforCytotoxicity2.2CodeofFederalRegulations3:CFR,Title21,Section191,II,19713.Terminology3.1Definitions:3.1.1ThedefinitionsgiveninTerminologyE344applytothisstandard.3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1phase-change-typefeverthermometer,n—areusableinstrumentutilizingthechangeofstateofchemicalcomposi-tionstomeasureandindicateananatomicalsitetemperature.3.2.2retentiontime,n—thedurationoftimethattheoptimalsignalforreadingpersists.4.Classification4.1Phase-change-typereusablethermometersfordetermi-nationofhumantemperature.4.2Scales,CelsiusandFahrenheit.5.Requirements5.1General—Allthermometerscomplyingwiththisspeci-ficationshallmeetalltherequirementsspecifiedherein.5.2TemperatureRange—Theinstrumentshallcovertheminimumrangefrom35.5to40.4°C(96.0to104.8°F).5.3Accuracy—Withintherangespecified,noindividualreadingshallbeinerrorbymorethanthemaximumerrorslistedinTable1whentestedinaccordancewith6.2atanypointonthetemperaturescaleofthethermometer.5.4MeasurementRetention—Am...
