ASTM E1112-2000(2006) 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格》.pdf

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1、Designation: E 1112 00 (Reapproved 2006)Standard Specification forElectronic Thermometer for Intermittent Determination ofPatient Temperature1This standard is issued under the fixed designation E 1112; the number immediately following the designation indicates the year oforiginal adoption or, in the

2、 case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers electronic instruments in-tended for intermittent monitoring

3、 of patient temperatures.1.2 This specification does not cover infrared thermometers.Specification E 1965 covers specifications for IR thermom-eters.1.3 The values stated in SI units are to be regarded as thestandard.1.4 The following precautionary caveat pertains only to thetest method portion, Sec

4、tion 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 limit

5、ations prior to use.2. Referenced Documents2.1 ASTM Standards:2E 344 Terminology Relating to Thermometry and Hydrom-etryE 1104 Specification for Clinical Thermometer Probe Cov-ers and SheathsE 1965 Specification for Infrared Thermometers for Inter-mittent Determination of Patient Temperature2.2 Unde

6、rwriters Laboratory Standards:3UL 544 Standards for Safety, Medical 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 Establish

7、ment Registration and PremarketNotification Procedure3. Terminology3.1 Definitions:3.1.1 The definitions given in Terminology E 344 shallapply to this specification.3.2 Definitions of Terms Specific to This Standard:3.2.1 battery charger, nelectrical circuit designed to re-store the electrical poten

8、tial 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 devic

9、e 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 dev

10、ice. (See “Good ManufacturingPractices,” Part 807 Code of Federal 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

11、temperature of the measurementsite in advance of the time necessary 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

12、sheath, ndevice provided for thepurpose of preventing biological contact between the patientand probe (see Specification E 1104).3.2.9 IR thermometer, noptoelectronic instrument that iscapable of noncontact infrared temperature measurement whenplaced into the auditory canal of a subject (ear canal t

13、ype) orfrom the subjects body surface (skin type).1This specification is under the jurisdiction of ASTM Committee E20 onTemperature Measurement and is the direct responsibility of Subcommittee E20.08on Medical Thermometry.Current edition approved May 1, 2006. Published May 2006. Originallyapproved i

14、n 1986. Last previous edition approved in 2000 as E 1112 00.2For 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.3

15、Available from Underwriters Laboratories (UL), Corporate Progress, 333Pfingsten Rd., Northbrook, IL 60062.4Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852.5Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop:

16、SDE, Washington, DC 20401.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.10 transducer, ndevice that provides a measurableoutput (for example, resistance, emf, etc.) as a function oftemperature.4. Requirements4.1 Temperature ran

17、geAs a minimum, the instrumentshall display temperature over the following range: 35.5 to 41.0C (96.0 to 106.0 F).4.2 AccuracyWithin the manufacturers specified tem-perature range for patient temperature measurement, no indi-vidual reading shall be in error by more than the values shownin Table 1.4.

18、3 Environment:4.3.1 Operating EnvironmentThe instrument must meetthe accuracy requirements of 4.2 when operated in an environ-ment of 16 to 40 C (60.8 to 104 F) and a relative humidity of15 to 95 % noncondensing.4.3.2 Storage EnvironmentThe instrument shall meet therequirements of 4.2 after having b

19、een stored or transported, orboth, at any point in an environment of 20 to 50 C (4 to 120F), and a relative humidity of 15 to 95 %, noncondensing, fora period of one month.4.3.3 LabelingThe instruction manual shall include astatement that informs the user if the performance of the devicemay be degra

20、ded 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 Patient temperature is below amb

21、ient 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 0.1 C. Allfull-degree graduations shall be long time. Half-degree gradu-ations may be long lines. All other

22、 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 GraduationsFahrenheit disp

23、lay ther-mometers shall be graduated in intervals of not greater than 0.2F. All full-degree graduations shall be long lines (see 4.4.1.3and 4.4.1.5). Half-degree graduations may be long lines. Allother graduations shall be short lines. Appropriate numeralsshall be placed as a minimum at every even d

24、egree graduation.Graduation lines shall be spaced at least 0.55 mm (0.022 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 lines. The lines shall b

25、e 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 spacing between gradu

26、ation marks (see4.4.1.1 or 4.4.1.2).4.4.1.5 Reference MarkingThe line at 37 C (98.6 F)may 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 ResolutionThe di

27、gital display shall have incre-mental steps of not more than 0.1 C or 0.1 F.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 least 0.7 mm

28、 (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 conditi

29、on 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 require

30、mentsof 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.4.6.2

31、.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 must b

32、e 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 which t

33、he thermometer wascalibrated) and temperature scale, Celsius or Fahrenheit. Cel-sius or Fahrenheit may be abbreviated.TABLE 1 Maximum Error Temperature RangesTemperature Maximum ErrorCelsius Scale:Less than 35.8 C 60.3 C35.8 C to less than 37 C 60.2 C37.0Cto39.0C 60.1 CGreater than 39.0 C to 41.0 C

34、60.2 CGreater than 41.0 C 60.3 CFahrenheit Scale:Less than 96.4 F 60.5 F96.4 F to less than 98.0 F 60.3 F98.0 F to 102.0 F 60.2 FGreater than 102.0 F to 106.0 F 60.3 FGreater than 106.0 F 60.5 FE 1112 00 (2006)24.7.2 Probe MarkingDetachable reusable probes shall bemarked with at least the manufactur

35、ers or distributors 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

36、 Care and Use InstructionsInstructions 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 deconta

37、minate, following 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 r

38、equirements of UL 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 complian

39、ce in conjunc-tion 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 E 1112. Full responsibility for conforman

40、ce of thisproduct to 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 E 1112 (name and address ofproducer or distributor).4.8 Doc

41、umentation:4.8.1 Detailed 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 M

42、anualA service manual 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 DeterminationMa

43、nufacturer shall makeavailable 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.

44、8.4 RecalibrationThe 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 orfi

45、xtures required for 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 (se

46、e4.1), accuracy (see 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. V

47、erificationprocedures 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

48、section.With the exceptions 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

49、 mini-mum of five times. This shall result in no significant discol-oration, detriment to operation, nor degradation of electricalsafety.5.3 Toxicity TestTest materials intended for patient con-tact in accordance with current issue of USP BiologicalTest-Plastic Container, Table 1 (Extract of sample in sodiumchloride and extract of sample in vegetable oil).5.4 Accuracy TestPerform the following tests in accor-dance with manufacturers user procedures for measuringhuman temperatures.5.4.1 Test