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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 Coversand SheathsE1965 Specification for Infrared Thermometers for Intermit-tent Determination of Patient Temperature2.2 Underwriters Laboratory Standards:3UL544 Standards for Safety, Medica

7、l 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. Terminolo

8、gy3.1 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

9、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

10、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

11、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 necessar

12、y 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. Publish

13、ed 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,

14、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. Governme

15、nt 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 States13.2.7 probe, nassembly, including the transducer, th

16、at 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 instru

17、ment 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 oftemperatur

18、e.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 more th

19、an 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 therequir

20、ements 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 performance o

21、f 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 Patient

22、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 may b

23、e 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 Gradu

24、ationsFahrenheit 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 a min

25、imum 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 lines. T

26、he 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 spacing be

27、tween graduation marks (see4.4.1.1 or 4.4.1.2).4.4.1.5 Reference MarkingThe line at 37 C 98.6 F maybe designated by an arrow or other suitable mark. If a referencemark is used, the position shall be within a tolerance ofone-half of the minimum graduated interval.4.4.2 Digital Display:4.4.2.1 Resolut

28、ionThe 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 theinstrument, the numerals shall appear to be at least 2.5 mm 0.1in. high and 1.5 mm 0.059 in. wide and appear to beseparated from one another by a space of at least 0.7 m

29、m0.027 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 condition

30、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 requiremen

31、tsof 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.TABLE 1

32、Maximum Error Temperature RangesTemperature Maximum ErrorCelsius Scale:Less than 35.8C 0.3C35.8C to less than 37C 0.2C37.0C to 39.0C 0.1CGreater than 39.0C to 41.0C 0.2CGreater than 41.0C 0.3CFahrenheit Scale:Less than 96.4F 0.5F96.4F to less than 98.0F 0.3F98.0F to 102.0F 0.2FGreater than 102.0F to

33、 106.0F 0.3FGreater than 106.0F 0.5FE1112 00 (2011)24.6.2.2 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 mar

34、kings for purposes of identification orinstruction must 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, modeldesignation, serial number or lot number (to indicat

35、e thespecific period, not to exceed 90 days, in which the thermom-eter was calibrated) and temperature scale, Celsius or Fahren-heit. Celsius or Fahrenheit may be abbreviated.4.7.2 Probe MarkingDetachable reusable probes shall bemarked with at least the manufacturers or distributors nameor identific

36、ation 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 InstructionsInstructio

37、ns 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 each use, any pati

38、ent 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 913, a warning lab

39、el, as defined in UL544, 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 with their name a

40、nd 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 to the specificatio

41、n 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 Detailed Instructions

42、Detailed 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 manual shallbe made ava

43、ilable if user repair is permitted by the manufac-turer. The service manual shall provide theory of operation,maintenance information, test procedures, test equipmentrequirements, detailed diagrams, parts list, and specifications.4.8.3 Accuracy DeterminationManufacturer shall makeavailable specific

44、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 manufacturer shall

45、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 adjustment must eith

46、er 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 4.2), and environme

47、nt (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. Verificationprocedures are not included f

48、or 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 exceptions of the poten

49、tially 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 significantdiscoloration, detriment to operation, nor degradation of elec-trical safety.5.3 Toxicity TestTest materials intended