ASTM_E_1299_-_96_2016.pdf

Designation:E129996(Reapproved 2016)Standard Specification forReusable Phase-Change-Type Fever Thermometer forIntermittent Determination of Human Temperature1This standard is issued under the fixed designation E1299;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers reusable phase-change-typeclinical thermometers.1.2 The following safety hazards caveat pertains only to thetest method portion,Section 6,of this specification.Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.Referenced Documents2.1 ASTM Standards:2E344 Terminology Relating to Thermometry and Hydrom-etryF895 Test Method forAgar Diffusion Cell Culture Screeningfor Cytotoxicity2.2 Code of Federal Regulations3:CFR,Title 21,Section 191,II,19713.Terminology3.1 Definitions:3.1.1 The definitions given in Terminology E344 apply tothis standard.3.2 Definitions of Terms Specific to This Standard:3.2.1 phase-change-type fever thermometer,na reusableinstrument utilizing the change of state of chemical composi-tions to measure and indicate an anatomical site temperature.3.2.2 retention time,nthe duration of time that the optimalsignal for reading persists.4.Classification4.1 Phase-change-type reusable thermometers for determi-nation of human temperature.4.2 Scales,Celsius and Fahrenheit.5.Requirements5.1 GeneralAll thermometers complying with this speci-fication shall meet all the requirements specified herein.5.2 Temperature RangeThe instrument shall cover theminimum range from 35.5 to 40.4 C(96.0 to 104.8 F).5.3 AccuracyWithin the range specified,no individualreading shall be in error by more than the maximum errorslisted in Table 1 when tested in accordance with 6.2 at anypoint on the temperature scale of the thermometer.5.4 Measurement RetentionA measurement meeting theaccuracy requirement of 5.3 will be maintained for a minimumof 20 s when tested in accordance with 6.2.4.5.5 Operating EnvironmentWhen used in an environmentin which the temperature is in the range of 18 to 33 C(64 to92 F),the thermometers,when tested in accordance with 6.3,shall meet the requirements of 5.3 and 5.4.5.6 GraduationThe thermometer shall be graduated inintervals no greater than 0.1 C(0.2 F).As a minimum,appropriate numerals shall be placed at every half degreegraduation for Celsius scale thermometers and every degreegraduation for Fahrenheit scale thermometers.5.7 StabilityThermometers shall meet all requirements ofthis specification over their minimum shelf life of three years.5.8 Storage EnvironmentWhen tested in accordance with6.4,thermometers shall meet the requirements of 5.3 afterhaving been stored in an environment of 20 to 50 C(+4 Fto 120 F),and a relative humidity of 15 to 85%noncondensing,for a period of thirty days,providing that theyhave been returned to an environment with a temperature ofbetween 18 to 33 C(64 to 92 F)and a relative humidity of30 to 70%for at least 24 h before testing.5.9 Marking and Labeling:5.9.1 IdentificationSuitable packaging units of the ther-mometer shall bear in legible characters the name or1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Oct.1,2016.Published October 2016.Originallyapproved in 1989.Last previous edition approved in 2010 as E1299 96(2010).DOI:10.1520/E1299-96R16.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 trademark,or both,of the manufacturer or distributor and adesignation(either a serial number or a code)to indicate thespecific manufacturing lot.5.9.2 Operating InstructionsOperating instructions shallbe provided with the packaging unit.5.9.3 Care and Cleaning InstructionsInstructions for thecare and cleaning of the thermometer shall be provided withthe packaging unit.A procedure for decontaminating thethermometer following each use shall be included with theseinstructions.5.10 ToxicityWhen the thermometer is used as specifiedby the manufacturer,the parts intended for contact with intactnatural channels