ASTM E1112-2000(2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature《间歇测定病人温度用电子温度计的标准规范》.pdf

1、Designation: E1112 00 (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 c

2、ase 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

3、 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 equi

4、valents; 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

5、 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 Standard

6、s:2E344 Terminology Relating to Thermometry and Hydrom-etryE1104 Specification for Clinical Thermometer Probe Cov-ers and SheathsE1965 Specification for Infrared Thermometers for Inter-mittent Determination of Patient Temperature2.2 Underwriters Laboratory Standards:3UL 544 Standards for Safety, Med

7、ical and Dental Equip-mentUL 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 PremarketNotification Procedure3. Termino

8、logy3.1 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 th

9、e 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 provide

10、s 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 Federa

11、l Regulations 6.)3.2.5 measurement time, nthat time required from thetime of patient contact to display of temperature to within thestated accuracy.3.2.6 predictive thermometer, none that provides an indi-cation of the final stabilized temperature of the measurementsite in advance of the time necess

12、ary for the transducer to reacha stabilized temperature.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

13、 contact between the patientand probe (see Specification E1104).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, 201

14、1. 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 inf

15、ormation, refer to the standards Document Summary page onthe ASTM website.3Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., North-brook, IL 60062-2096, http:/.4Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.5Available from U

16、.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.9 IR thermometer, noptoelectronic i

17、nstrument 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 oftempe

18、rature.4. Requirements4.1 Temperature rangeAs a minimum, the instrumentshall display temperature over the following range: 35.5 to41.0C 96.0 to 106.0F.4.2 AccuracyWithin the manufacturers specified tem-perature range for patient temperature measurement, no indi-vidual reading shall be in error by mo

19、re than the values shownin Table 1.4.3 Environment:4.3.1 Operating EnvironmentThe instrument must meetthe accuracy requirements of 4.2 when operated in an environ-ment of 16 to 40C 60.8 to 104F and a relative humidity of15 to 95 % noncondensing.4.3.2 Storage EnvironmentThe instrument shall meet ther

20、equirements of 4.2 after having been stored or transported, orboth, at any point in an environment of 20 to 50C 4 to120F, and a relative humidity of 15 to 95 %, noncondensing,for a period of one month.4.3.3 LabelingThe instruction manual shall include astatement that informs the user if the performa

21、nce of the devicemay be degraded should one or more of the following occur:4.3.3.1 Operation outside the manufacturers stated tem-perature and humidity range.4.3.3.2 Storage outside the manufacturers stated tempera-ture and humidity range.4.3.3.3 Mechanical shock (for example, drop test).4.3.3.4 Pat

22、ient temperature is below ambient temperature(operating environment see 4.3.1).4.4 Resolution:4.4.1 Analog Display:4.4.1.1 Celsius GraduationsCelsius display thermometersshall be graduated in intervals of not greater than 0.1C. Allfull-degree graduations shall be long time. Half-degree gradu-ations

23、may be long lines. All other graduations shall be shortlines (see 4.4.1.3). As a minimum, appropriate numerals shallbe at every full-degree graduation except the numeral 37,which is optional (see 4.4.1.5). Graduation lines shall bespaced at least 0.50 mm 0.02 in. center to center.4.4.1.2 Fahrenheit

24、GraduationsFahrenheit display ther-mometers shall be graduated in intervals of not greater than0.2F. All full-degree graduations shall be long lines (see4.4.1.3 and 4.4.1.5). Half-degree graduations may be longlines. All other graduations shall be short lines. Appropriatenumerals shall be placed as

25、a minimum at every even degreegraduation. Graduation lines shall be spaced at least 0.55 mm0.022 in. center to center.4.4.1.3 Scales Graduation MarksAll short graduationlines shall not be less than 1.3 mm 0.05 in. in length.All longgraduation lines shall be no less than 25 % longer than theshort lin

26、es. The lines shall be essentially straight and in linewith the pointer. They shall not be wider than the spacesbetween the graduations, nor wider than 0.45 mm 0.018 in.and shall not be narrower than 0.10 mm 0.004 in.4.4.1.4 Pointer WidthThe pointer shall have a maximumwidth of one-half of the spaci

27、ng between graduation marks (see4.4.1.1 or 4.4.1.2).4.4.1.5 Reference MarkingThe line at 37 C 98.6 Fmay be designated by an arrow or other suitable mark. If areference mark is used, the position shall be within a toleranceof one-half of the minimum graduated interval.4.4.2 Digital Display:4.4.2.1 Re

28、solutionThe digital display shall have incre-mental steps of not more than 0.1C or 0.1F.4.4.2.2 ReadabilityAt the outside surface of the instru-ment, the numerals shall appear to be at least 2.5 mm 0.1 in.high and 1.5 mm 0.059 in. wide and appear to be separatedfrom one another by a space of at leas

29、t 0.7 mm 0.027 in.4.5 Battery ConditionWhen battery operated, the instru-ment accuracy and condition shall not be affected by batterycondition unless a continuous automatic indication of unreli-able condition is provided. The indication of unreliable condi-tion must be presented until the battery co

30、ndition is corrected.When an instrument uses a rechargeable battery, a positionindication shall be provided with the instrument system toindicate that the battery is charging.4.6 Construction:4.6.1 ElectricalThe instrument and accessories (such asbattery chargers) shall meet the electrical safety re

31、quirementsof UL 544 (see 5.3).4.6.2 Material:4.6.2.1 Case MaterialThe case material of the instrumentand nondisposable accessories shall withstand biological andphysical cleaning without performance degradation (see 5.2). Itshall also withstand dropping without presenting an electricalsafety hazard.

32、4.6.2.2 Patient Contact MaterialsThose parts of the elec-tronic thermometer system intended for contact with anatomi-cal sites for the purpose of temperature measurement asspecified by the manufacturer shall be nontoxic (see 5.3).4.7 MarkingAll markings for purposes of identification orinstruction m

33、ust be clear and legible. Deterioration shall notoccur when subjected to cleaning (see 5.2).4.7.1 Instrument MarkingThe instrument shall be markedwith the manufacturers or distributors name, model designa-tion, serial number or lot number (to indicate the specificperiod, not to exceed 90 days, in wh

34、ich the thermometer wasTABLE 1 Maximum Error Temperature RangesTemperature Maximum ErrorCelsius Scale:Less than 35.8C 60.3C35.8C to less than 37C 60.2C37.0C to 39.0C 60.1CGreater than 39.0C to 41.0C 60.2CGreater than 41.0C 60.3CFahrenheit Scale:Less than 96.4F 60.5F96.4F to less than 98.0F 60.3F98.0

35、F to 102.0F 60.2FGreater than 102.0F to 106.0F 60.3FGreater than 106.0F 60.5FE1112 00 (2011)2calibrated) and temperature scale, Celsius or Fahrenheit. Cel-sius or Fahrenheit may be abbreviated.4.7.2 Probe MarkingDetachable reusable probes shall bemarked with at least the manufacturers or distributor

36、s nameor identification and serial or lot number.4.7.3 Operating InstructionsOperating instructions shallbe provided on the instrument. When space requirementsdictate, the operating instructions on the instrument may bebrief if detailed operating instruction are also provided.4.7.4 Care and Use Inst

37、ructionsInstructions for the care,use, and biological and physical cleaning of the instrumentshall be provided. Proper use and application of specialattachments, such as oral or rectal probes and probe covers,shall be indicated. The manufacturer shall provide instructionsto decontaminate, following

38、each use, any patient contactcomponent not intended for single use.4.7.5 Health and Safety Hazard Marking Notices shall bedisplayed on the instrument if possible.4.7.5.1 Hazardous Environmental Safety WarningIf theinstrument or accessories (such as battery charger) do not meetthe requirements of UL

39、913, a warning label, as defined inUL 544, shall be placed on the instrument or accessory.4.7.6 Identification:4.7.6.1 In order that purchasers may identify products con-forming to all requirements of this specification, producers anddistributors may include a statement of compliance in conjunc-tion

40、 with their name and address on product labels, invoices,sales literature, and the like. The following statement issuggested when sufficient space is available: This thermometerconforms to all of the requirements established in ASTMstandard E1112. Full responsibility for conformance of thisproduct t

41、o the specification is assumed by (name and address ofproducer or distributor).4.7.6.2 The following abbreviated statement is suggestedwhen available space on labels is insufficient for the fullstatement: Conforms to ASTM E1112 (name and address ofproducer or distributor).4.8 Documentation:4.8.1 Det

42、ailed InstructionsDetailed instructions for useshall be provided. These instructions shall contain sufficientdetail to provide a means for training in the operation,application, care, and biological and physical cleaning of theinstrument and accessories.4.8.2 Service and Repair ManualA service manua

43、l shallbe made available if user repair is permitted by the manufac-turer. The service manual shall provide theory of operation,maintenance information, test procedures, test equipment re-quirements, detailed diagrams, parts list, and specifications.4.8.3 Accuracy DeterminationManufacturer shall mak

44、eavailable specific instructions for test to determine the accuracyof the instrument, including the temperature probe. Manufac-turers of predictive thermometers must specify corrections tocompensate for the difference between in vivo and vitroconditions if required (see 5.4.2).4.8.4 RecalibrationThe

45、 manufacturer shall recommend aperiodic recalibration cycle to ensure continuous performanceto the requirements of 4.2. The manufacturer shall providespecific instructions for the adjustment of the instrument if useradjustment is permitted by the manufacturer. Test equipment orfixtures required for

46、adjustment must either be described insufficient detail to permit fabrication or purchase; or, manufac-turers equipment or fixtures must be made available to users.4.8.5 Detailed SpecificationsThe manufacturer shall pro-vide specifications of the instruments temperature range (see4.1), accuracy (see

47、 4.2), and environment (see 4.3).5. Performance Tests5.1 Significance and UseThis section describes apparatusand procedures for verifying conformance to certain perfor-mance requirements of Section 4. These tests are not requiredof the manufacturer unless specified by the user. Verificationprocedure

48、s are not included for requirements that can beverified by observation or inspection, or where a standardprocedure is not needed (such as the requirements of 4.4.1).The manufacturer shall certify that the product will complywith the requirements if tested in accordance with this section.With the exc

49、eptions of the potentially destructive tests, anysingle electronic thermometer shall be capable of undergoingthe following tests in any sequence without impairment ofperformance.5.2 Cleaning TestsPerform the manufacturers recom-mended biological and physical cleaning procedures a mini-mum of five times. This shall result in no significant discolor-ation, detriment to operation, nor degradation of electricalsafety.5.3 Toxicity TestTest materials intended