1、Designation: E1299 96 (Reapproved 2016)Standard Specification forReusable Phase-Change-Type Fever Thermometer forIntermittent Determination of Human Temperature1This standard is issued under the fixed designation E1299; the number immediately following the designation indicates the year oforiginal a
2、doption 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 reusable phase-change-typeclinical thermome
3、ters.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 appropriate s
4、afety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2E344 Terminology Relating to Thermometry and Hydrom-etryF895 Test Method forAgar Diffusion Cell Culture Screeningfor Cytotoxicity2.2 Code of Federal Regulation
5、s3:CFR, Title 21, Section 191, II, 19713. Terminology3.1 Definitions:3.1.1 The definitions given in Terminology E344 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 chemical com
6、posi-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. Require
7、ments5.1 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 40.4 C (96.0 to 104.8 F).5.3 AccuracyWithin the range specified, no individualreading shall be in error b
8、y 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 6.2.4.5.5 Op
9、erating EnvironmentWhen used in an environmentin which the temperature is in the range of 18 to 33 C (64 to92 F), 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 0.1 C (0.2 F)
10、. 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.5.8 S
11、torage EnvironmentWhen tested in accordance with6.4, thermometers shall meet the requirements of 5.3 afterhaving been stored in an environment of 20 to 50 C ( + 4 Fto 120 F), and a relative humidity of 15 to 85 %noncondensing, for a period of thirty days, providing that theyhave been returned to an
12、environment with a temperature ofbetween 18 to 33 C (64 to 92 F) and a relative humidity of30 to 70 % for at 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 or1This specification is under th
13、e 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 Oct. 1, 2016. Published October 2016. Originallyapproved in 1989. Last previous edition approved in 2010 a
14、s E1299 96 (2010).DOI: 10.1520/E1299-96R16.2For 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 U.
15、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 States1trademark, or both, of the manufacturer o
16、r 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 thermometer shall b
17、e provided withthe packaging unit. A procedure for decontaminating thethermometer 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 surfaces
18、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,apparatus, and procedures to be used to determine the confor-mance of phase change reusable thermometers to
19、the require-ments of this standard. Each manufacturer or distributor whenrepresenting products as conforming to this standard may usestatistically based sampling plans that are appropriate. Suchessential records as are necessary to document claims that all ofthe requirements of this specification ar
20、e met shall be main-tained.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 60.03 C(60.05 F), as measured by a thermometer or thermometersystem for which the temperature ca
21、libration 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.4The volumeof each bath shall be a minimum of 1 L.6.2.2 ProcedureInsert the thermometers in the water bath
22、and 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,mak
23、ing 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 thethermomet
24、ers from the water bath. These thermometers shallmeet the requirements of 5.3 at the temperature extremes of 18and 33 C (64 and 92 F) 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 o
25、f5.5.6.3.1 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(906 2 F),6.3.1.3 Refrigerated Chamber, capable of cooling samplesto 19 6 1C(666 2 F).NOTE 1The oven and refrigerator must be located in close proximit
26、yto 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 32 C (66 and 92 F), for atleast 1 h. Remove the thermometers from these operatingenvironments and insert them
27、into the test water bath within 10s of removal from either the 32 C 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.
28、4.1.1 Constant-Temperature Water Baths, (6.2.1).6.4.1.2 Environmental Test Chamber, capable of producingenvironments of 206 2C(46 4 F) at 15 and 85 %relative humidities and 50 6 2 C (120 6 4 F) at 30 % relativehumidity is required. Humidity conditions should be madeuniform and reproducible. Relative
29、 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
30、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
31、 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 F895. If the samples pass this test,there is reasonable assurance that the test animals will not suffer. Shouldthe samples fail this test, careful consi
32、deration should be made beforeproceeding to 6.5 and 6.6.4Available from National Institute of Standards and Technology (NIST), 100Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http:/www.nist.gov.TABLE 1 Maximum Error of Temperature ReadingsCelsius ScaleTemperature Range, C Maximum Error, CBelo
33、w 35.8 0.335.8 to 36.9 0.237.0 to 39.0 0.139.1 to 40.4 0.2Fahrenheit ScaleTemperature Range, F Maximum Error, FBelow 98.0 0.498.0 to 102.0 0.2Above 102.0 0.4E1299 96 (2016)26.5 Toxicity Test (Extract)Place one hundred samples in100 mL of a 0.85 weight percent NaCl solution and store in anoven at 45
34、C for a period of time equal to 100 times themaximum patient measurement time recommended by themanufacturer. Use this 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 t
35、est, National Formulary XIII.56.5.3 Primary skin irritation test, CFR, Title 21, Section191, II, 1971. The thermometers will be considered nontoxic ifthe extract produces reactions which are not significantlydifferent from a control (saline) sample.6.6 Toxicity Test (Chemical Ingestion)Determine the
36、 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 a
37、dministered to a 100-g rat is 0.0008 g(0.002 100 1002500 = 0.0008 g). These rats must be ob-served 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 the co
38、ntrol 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 Section
39、 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. The fo
40、llowing statement issuggested when sufficient space is available:7.1.1 “This thermometer conforms to all the requirementsestablished in ASTM Specification E1299. Full responsibilityfor the conformance of this product to the specification isassumed by (name and address of distributor or producer).7.2
41、 When the available space is insufficient for this fullstatement, the following abbreviated statement is suggested:7.2.1 Conforms to ASTM Specification E1299 (name andaddress of distributor or producer).ASTM International takes no position respecting the validity of any patent rights asserted in con
42、nection 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 respon
43、sible 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 careful
44、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 International, 1
45、00 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ from United States Pharmacopia Convention, Inc., 12601 TwinbrookParkway, Rockville, MD 20852.E1299 96 (2016)3
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