ASTM_E_1965_-_98_2009.pdf

Designation:E196598(Reapproved 2009)Standard Specification forInfrared Thermometers for Intermittent Determination ofPatient Temperature1This standard is issued under the fixed designation E1965;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 electronic instruments in-tended for intermittent measuring and monitoring of patienttemperatures by means of detecting the intensity of thermalradiation between the subject of measurement and the sensor.1.2 The specification addresses assessing subjects bodyinternal temperature through measurement of thermal emissionfrom the ear canal.Performance requirements for noncontacttemperature measurement of skin are also provided.1.3 The specification sets limits for laboratory accuracy andrequires determination and disclosure of clinical accuracy ofthe covered instruments.1.4 Performance and storage limits under various environ-mental conditions,requirements for labeling and test proce-dures are established.NOTE1For electrical safety consult Underwriters Laboratory Stan-dards.2NOTE2For electromagnetic emission requirements and tests refer toCISPR 11:1990 Lists of Methods of Measurement of ElectromagneticDisturbance Characteristics of Industrial,Scientific,and Medical(ISM)Radiofrequency Equipment.31.5 The values of quantities stated in SI units are to beregarded as the standard.The values of quantities in parenthe-ses are not in SI and are optional.1.6 The following precautionary 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:4E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE344 Terminology Relating to Thermometry and Hydrom-etryE667 Specification for Mercury-in-Glass,Maximum Self-Registering Clinical ThermometersE1112 Specification for Electronic Thermometer for Inter-mittent Determination of Patient Temperature2.2 International Electrotechnical Commission Standards:IEC 601-1-2:1993 Medical Electrical Equipment,Part 1;General Requirements for Safety.Collateral Standard:Electromagnetic CompatibilityRequirements and Tests3IEC1000-4-2:1995ElectromagneticCompatibility(EMC)Part 4:Testing and Measurement Techniques;Section 2:Electrostatic Discharge Immunity Test:BasicEMC Publication(Rev.of IEC 801-2)3IEC 1000-4-3:1995 Electromagnetic Compatibility32.3 Other Standards:International Vocabulary of Basic and General Terms inMetrology(VIM)33.Terminology3.1 DefinitionsThe definitions given in Terminology E344apply.3.2 Definitions of Terms Specific to This Standard:3.2.1 The terms defined below are for the purposes of thisspecification only.Manufacturers should use this terminologyin labeling instruments and in technical and sales literature.3.2.2 accuracy,nability of an infrared thermometer togive a reading close to the true temperature.3.2.3 adjusted mode,noutput of an IR thermometer thatgives temperature measured and calculated from a subject orobject,by correcting such temperature for variations in ambi-ent temperature,subjects temperature,emissivity,body site(that is,oral,or rectal),etc.1This 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 May 1,2009.Published July 2009.Originally approvedin 1998.Last previous edition approved in 2003 as E1965 98(2003).DOI:10.1520/E1965-98R09.2Available from Underwriters Laboratories Inc.,1655 Scott Blvd.,Santa Clara,CA 95050.3Available from Global Engineering Documents,15 Inverness Way East,Englewood,CO 80112.4For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.4 axillary temperature tba,ntemperature at the apexof either axilla(armpit)as measured by a contact thermometer.3.2.5 blackbody,na reference source of infrared radiationmade in the shape of a cavity and characterized by preciselyknown temperature of the cavity walls and having effectiveemissivity at the cavity opening arbitrarily considered equal tounity.3.2.6 blackbody temperature tBB,ntemperature ofblackbody cavity walls as measured by an imbedded orimmersed contact thermometer.3.2.7 bladd