ASTM_E_1112_-_00_2011.pdf

Designation:E111200(Reapproved 2011)Standard Specification forElectronic Thermometer for Intermittent Determination ofPatient Temperature1This standard is issued under the fixed designation E1112;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 monitoring of patient temperatures.1.2 This specification does not cover infrared thermometers.Specification E1965 covers specifications for IR thermometers.1.3 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.1.4 The following precautionary caveat pertains only to thetest method portion,Section 5,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 theusers of this standard to consult and establish appropriatesafety and health practices and determine the applicability ofregulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E344 Terminology Relating to Thermometry and Hydrom-etryE1104 Specification for Clinical Thermometer Probe Coversand SheathsE1965 Specification for Infrared Thermometers for Intermit-tent Determination of Patient Temperature2.2 Underwriters Laboratory Standards:3UL544 Standards for Safety,Medical and Dental EquipmentUL 913 Standards for Safety,Intrinsically Safe ElectricalCircuits and Equipment for Use in Hazardous Location2.3 U.S.Pharmacopeia:4USP Latest Issue Biological Test2.4 Federal Regulations:5CFR Part 87 Establishment Registration and Premarket No-tification Procedure3.Terminology3.1 Definitions:3.1.1 The definitions given in Terminology E344 shall applyto this specification.3.2 Definitions of Terms Specific to This Standard:3.2.1 battery charger,nelectrical circuit designed to re-store the electrical potential of a battery.3.2.2 distributor,nany person who furthers the marketingof a device from the original manufacturer to the person whomakes final delivery or sale to the ultimate consumer or userbut who does not repackage or otherwise change the container,wrapper,or labeling of the device or device package.3.2.3 electronic thermometer,ninstrument that provides adisplay of temperature sensed through the use of a transducerand electronic circuitry.3.2.4 manufacturer,nany person,including any repackeror relabeler,or both,who manufactures,fabricates,assembles,or reprocesses a finished device.(See“Good ManufacturingPractices,”Part 807 Code of Federal Regulations 6.)3.2.5 measurement time,nthat time required from the timeof patient contact to display of temperature to within the statedaccuracy.3.2.6 predictive thermometer,none that provides an indi-cation of the final stabilized temperature of the measurementsite in advance of the time necessary for the transducer to reacha stabilized temperature.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 June 1,2011.Published June 2011.Originallyapproved in 1986.Last previous edition approved in 2006 as E1112 00(2006).DOI:10.1520/E1112-00R11.2For 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 Underwriters Laboratories(UL),333 Pfingsten Rd.,Northbrook,IL 60062-2096,http:/.4Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.5Available 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 3.2.7 probe,nassembly,including the transducer,that isused to position the transducer in the specific location at whichthe temperature is to be determined.3.2.8 probe cover and sheath,ndevice provided for thepurpose of preventing biological contact between the patientand probe(see Specification E1104).3.2.9 IR thermometer,noptoelectronic instrument that iscapable of noncontact infrared temperature measurement whenplaced into the auditory canal of a subject(ear canal type)orfrom the subjects body surface(skin type).3.2.10 transducer,ndevice that provides a measurableoutput(for example,resistance,emf,etc.)as a function