1、Designation: E 1299 96 (Reapproved 2002)Standard Specification forReusable Phase-Change-Type Fever Thermometer forIntermittent Determination of Human Temperature1This standard is issued under the fixed designation E 1299; the number immediately following the designation indicates the year oforiginal
2、 adoption or, in the 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 reusable phase-change-typeclinical therm
3、ometers.1.2 The following safety hazards 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 appropriat
4、e safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:E 344 Terminology Relating to Thermometry and Hydrom-etry2F 895 Test Method for Agar Diffusion Cell Culture Screen-ing for Cytotoxicity32.2 Code of Federal R
5、egulations4:CFR Title 21, Section 191, II, 19713. Terminology3.1 Definitions:3.1.1 The definitions given in Terminology E 344 apply tothis standard.3.2 Definitions of Terms Specific to This Standard:3.2.1 phase-change-type fever thermometer, na reusableinstrument utilizing the change of state of che
6、mical composi-tions to measure and indicate an anatomical site temperature.3.2.2 retention time, nthe duration of time that the optimalsignal for reading persists.4. Classification4.1 Phase-change-type reusable thermometers for determi-nation of human temperature.4.2 Scales, Celsius and Fahrenheit.5
7、. Requirements5.1 GeneralAll thermometers complying with this speci-fication shall meet all the requirements specified herein.5.2 Temperature RangeThe instrument shall cover theminimum range from 35.5 to 40.4C (96.0 to 104.8F).5.3 AccuracyWithin the range specified, no individualreading shall be in
8、error by more than the maximum errorslisted in Table 1 when tested in accordance with 6.2 at anypoint on the temperature scale of the thermometer.5.4 Measurement RetentionA measurement meeting theaccuracy requirement of 5.3 will be maintained for a minimumof 20 s when tested in accordance with 6.2.4
9、.5.5 Operating EnvironmentWhen used in an environmentin which the temperature is in the range of 18 to 33C (64 to92F), the thermometers, when tested in accordance with 6.3,shall meet the requirements of 5.3 and 5.4.5.6 GraduationThe thermometer shall be graduated inintervals no greater than 0.1C (0.
10、2F). As a minimum,appropriate numerals shall be placed at every half degreegraduation for Celsius scale thermometers and every degreegraduation for Fahrenheit scale thermometers.5.7 StabilityThermometers shall meet all requirements ofthis specification over their minimum shelf life of three years.5.
11、8 Storage EnvironmentWhen tested in accordance with6.4, thermometers shall meet the requirements of 5.3 afterhaving been stored in an environment of 20 to 50C ( + 4Fto 120F), and a relative humidity of 15 to 85 % noncondens-ing, for a period of thirty days, providing that they have beenreturned to a
12、n environment with a temperature of between 18to 33C (64 to 92F) and a relative humidity of 30 to 70 % forat least 24 h before testing.5.9 Marking and Labeling:5.9.1 IdentificationSuitable packaging units of the ther-mometer shall bear in legible characters the name or trade-mark, or both, of the ma
13、nufacturer or distributor and adesignation (either a serial number or a code) to indicate thespecific manufacturing lot.5.9.2 Operating InstructionsOperating instructions shallbe provided with the packaging unit.5.9.3 Care and Cleaning InstructionsInstructions for thecare and cleaning of the thermom
14、eter shall be provided withthe packaging unit. A procedure for decontaminating the1This 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 10, 1996. Publish
15、ed June 1996. Originallypublished as E 1299 89. Last previous edition E 1299 96.2Annual Book of ASTM Standards, Vol 14.03.3Annual Book of ASTM Standards, Vol 13.01.4Available from the Superintendent of Documents, US Government PrintingOffice, Washington, DC 20402.1Copyright ASTM International, 100 B
16、arr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.thermometer following each use shall be included with theseinstructions.5.10 ToxicityWhen the thermometer is used as specifiedby the manufacturer, the parts intended for contact with intactnatural channels or intact body
17、surfaces during patient use andits phase change chemical compositions shall be nontoxic asdetermined by 6.5.6. Test Methods for Performance Verification6.1 GeneralThis section describes the principles, appara-tus, and procedures to be used to determine the conformance ofphase change reusable thermom
18、eters to the requirements of thisstandard. Each manufacturer or distributor when representingproducts as conforming to this standard may use statisticallybased sampling plans that are appropriate. Such essentialrecords as are necessary to document claims that all of therequirements of this specifica
19、tion are met shall be maintained.6.2 Accuracy Test:6.2.1 Test Equipment RequiredThe test equipment shallinclude constant-temperature water baths, the temperatures ofwhich are uniform and are known to be within 60.03C(60.05F), as measured by a thermometer or thermometersystem for which the temperatur
20、e calibration is traceable to theInternational Temperature Scale of 1990 (ITS-90) as main-tained by the National Institute of Standards and Technology(NIST) or another national standards laboratory.5The volumeof each bath shall be a minimum of 1 L.6.2.2 ProcedureInsert the thermometers in the water
21、bathand test in accordance with the procedures specified by themanufacturer. Use at least 20 temperature points distributedthroughout the range on the scale of the thermometer forobtaining data.6.2.3 SamplingFor each manufacturing lot, use a mini-mum of 200 thermometers in the accuracy determination
22、,making at least five measurements with each thermometer. Thecriteria for lot acceptance shall be published by the manufac-turer.6.2.4 Measurement of Retention TimeAfter removingthermometers from the water bath, wait 20 s and compare thereadings with those obtained immediately upon removing thetherm
23、ometers from the water bath. These thermometers shallmeet the requirements of 5.3 at the temperature extremes of 18and 33C (64 and 92F) and the relative humidity extremes of15 and 85 %.6.3 Operating Environment TestThis test is used to deter-mine the compliance of the thermometers to the requirement
24、 of5.5.6.3.1 Test Equipment:6.3.1.1 Constant-Temperature Water Baths, (6.2.1),6.3.1.2 Forced-Circulation Air Oven, capable of heatingsamples to 32 6 1C (90 6 2F),6.3.1.3 Refrigerated Chamber, capable of cooling samplesto 19 6 1C (66 6 2F).NOTE 1The oven and refrigerator must be located in close prox
25、imityto the constant temperature water baths.6.3.2 ProcedureEquilibrate samples of thermometers inan immediate ready-to-use status (free of all packaging) at thetwo temperature extremes, 19 and 32C (66 and 92F), for atleast 1 h. Remove the thermometers from these operatingenvironments and insert the
26、m into the test water bath within 10s of removal from either the 32C oven or the 19 chamber andcomplete the accuracy test in accordance with 6.2.2 and 6.2.4.6.4 Storage Environment TestThis test is used to deter-mine the compliance of the thermometers to the requirementsof 5.8.6.4.1 Test Equipment:6
27、.4.1.1 Constant-Temperature Water Baths, (6.2.1).6.4.1.2 Environmental Test Chamber, capable of producingenvironments of 206 2C (4 6 4F) at 15 and 85 %relative humidities and 50 6 2C (120 6 4F) at 30 % relativehumidity is required. Humidity conditions should be madeuniform and reproducible. Relative
28、 humidities can be estab-lished using saturated solutions of common salts in deionizedwater.6.4.2 ProcedureSubject unopened storage packages ofthermometers to the four extreme combinations of temperatureand relative humidity indicated in 5.8. Hold them under theseconditions for 30 days. Remove the s
29、amples with their pack-aging unit intact from the test chambers and allow them toremain in an environment within its environmental operatingrange for 24 h. Then remove the thermometers from theirpackaging and complete the accuracy test in accordance with6.2.2 and 6.2.4.NOTE 2Toxicity tests: Prior to
30、 the animal testing as described in 6.5and 6.6 it is recommended that the extract and the chemical contents betested in accordance with Test Method F 895. If the samples pass this test,there is reasonable assurance that the test animals will not suffer. Shouldthe samples fail this test, careful cons
31、ideration should be made beforeproceeding to 6.5 and 6.6.6.5 Toxicity Test (Extract)Place one hundred samples in100 mL of a 0.85 weight percent NaCl solution and store in anoven at 45C for a period of time equal to 100 times themaximum patient measurement time recommended by themanufacturer. Use thi
32、s solution containing any extracts of thethermometers to perform the following tests.6.5.1 Acute oral toxicity in rats, (10 mL of extract/kg ofbody mass).6.5.2 Rabbit eye irritation test, National Formulary XIII.65Available from NIST, Gaithersburg, MD 20899.6Available from United States Pharmacopia
33、Convention, Inc., 12601 TwinbrookParkway, Rockville, MD 20852.TABLE 1 Maximum Error of Temperature ReadingsCelsius ScaleTemperature Range, C Maximum Error, CBelow 35.8 60.335.8 to 36.9 60.237.0 to 39.0 60.139.1 to 40.4 60.2Fahrenheit ScaleTemperature Range, F Maximum Error, FBelow 98.0 60.498.0 to 1
34、02.0 60.2Above 102.0 60.4E 129926.5.3 Primary skin irritation test, CFR, Title 21, Section191, 11, 1971. The thermometers will be considered nontoxicif the extract produces reactions which are not significantlydifferent from a control (saline) sample.6.6 Toxicity Test (Chemical Ingestion)Determine t
35、he av-erage mass of the chemical contents of one thermometer.Increase this amount 100 fold and administer orally to tenfasting 100-g rats an amount calculated pro rata based on 25 kg(weight of human child). For example, if a thermometerschemical contents have an average mass of 0.002 g, then themass
36、 administered to a 100-g rat is 0.0008 g(0.002 3 100 3 100/2500 = 0.0008 g). These rats must beobserved for 14 days and their reactions compared with aten-member control group of rats maintained on a normal diet.If, after 14 days, there is no death or retardation in the dosedanimals as compared to t
37、he control animals, the phase changechemical compositions are considered nontoxic.6.7 Cleaning TestsPerform the cleaning procedure asrecommended by the manufacturer a minimum of five times.This test shall result in no significant change of the thermom-eter in meeting the requirements set forth in Se
38、ction 5.7. Identification7.1 In order that purchasers may identify products conform-ing to all requirements of this specification, distributors andproducers may include a statement of compliance in conjunc-tion with their name and address on product labels, invoices,sales literature, and the like. T
39、he following statement issuggested when sufficient space is available:7.1.1 “This thermometer conforms to all the requirementsestablished in ASTM Specification E 1299. Full responsibilityfor the conformance of this product to the specification isassumed by (name and address of distributor or produce
40、r).7.2 When the available space is insufficient for this fullstatement, the following abbreviated statement is suggested:7.2.1 Conforms to ASTM Specification E 1299 (name andaddress of distributor or producer).ASTM International takes no position respecting the validity of any patent rights asserted
41、 in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the
42、 responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive c
43、areful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM Internati
44、onal, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).E 12993
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