1、Designation: E 825 98 (Reapproved 2009)Standard Specification forPhase Change-Type Disposable Fever Thermometer forIntermittent Determination of Human Temperature1This standard is issued under the fixed designation E 825; 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 () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defens
3、e.1. Scope1.1 This specification covers phase change-type clinicalthermometers that are designed and intended for one time use.2. Referenced Documents2.1 ASTM Standards:2E 344 Terminology Relating to Thermometry and Hydrom-etry2.2 Other Standards:National Formulary, Volume XIII Code of Federal Regul
4、a-tions, Title 21, Section 191, II 1971.3. Terminology3.1 DefinitionsThe definitions given in TerminologyE 344 apply.3.2 Definitions of Terms Specific to This Standard:3.2.1 intermittent determination of human temperature,ndetermination of human body temperature that is madeperiodically by a series
5、of entirely separate measurements.3.2.2 manufacturing lot, nin the case of a continuousmanufacturing process, a lot is a specific identified quantity oramount produced in a unit of time made in a manner thatassures its having uniform character and quality within speci-fied limits. In the case of a b
6、atch process, a lot means a batchor specific identified portion of a batch having uniformcharacter and quality within specified limits.3.2.3 measurement time, nlength of time required fromthe time of patient contact to the time when the thermometermay be removed to read within its stated accuracy.3.
7、2.4 predictive thermometer, nany thermometer that pro-vides an indication of the final stabilized temperature of themeasurement site in advance of the time for the sensing part ofthe thermometer to reach the equilibrium temperature of thatsite.3.2.5 storage package, nsmallest package intended by the
8、manufacturer for long-term storage at the users facility.3.2.6 suitable packaging unit, nunit(s) of packaging towhich a specific requirement of marking and labeling islogically applicable. It shall not be less than the smallest unitintended for sale by the manufacturer or distributor to the finaluse
9、r.3.2.7 temperature offset, ndesigned difference in predic-tive thermometer readings and water bath test temperatures.4. Classification4.1 Phase change disposable thermometers for the intermit-tent determination of human temperature.NOTE 1The requirements of this specification shall not preclude the
10、manufacture and sale of special thermometers having different tempera-ture ranges and degrees of subdivision designed for specific medical uses.Packaging on any “special” thermometers shall state that the thermometeris a special one intended for a specific use and, therefore, is not necessarilyin co
11、mpliance with this specification. In addition, the special thermometermust be marked in such a way as to identify it as “special.”4.2 Scales, Celsius and Fahrenheit.NOTE 2The Fahrenheit temperatures given in parentheses throughoutthis specification are not necessarily exact Celsius conversions but a
12、re thevalues to be used when testing thermometers with Fahrenheit scales forconformance with this specification.5. Requirements5.1 GeneralAll thermometers represented as complyingwith this specification shall meet all of the requirementsspecified herein. Terms are defined in Section 4.5.2 Temperatur
13、e RangeThe instrument shall cover theminimum range from 35 to 40.4 C (96 to 104.8 F) unlessotherwise obviously labeled. If any thermometer does not meet1This specification is under the jurisdiction of ASTM Committee E20 onTemperature Measurement and is the direct responsibility of Subcommittee E20.0
14、8on Medical Thermometry.Current edition approved May 1, 2009. Published June 2009. Originallyapproved in 1981. Discontinued February 1996 and reinstated as E 825 97. Lastprevious edition approved in 2003 as E 825 98 (2003).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orconta
15、ct ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.the range 35 to 40.4 C
16、(96 to 104.8 F), it shall additionally beobviously marked as “Limited Range” on suitable packagingunits.5.3 AccuracyThe accuracy of the thermometer shall be inconformance with Table 1 and Table 2 when tested in accor-dance with 6.2 at any point on the temperature scale of thethermometer.5.4 Measurem
17、ent RetentionA measurement meeting theaccuracy requirements of 5.3 will be maintained for a mini-mum of 1 min when tested in accordance with 6.2.4.5.5 Operating EnvironmentWhen used in an environmentin which the temperature is in the range from 18 to 33 C (64to 92 F), the thermometers, when tested i
18、n accordance with6.3, shall meet the requirements of 5.3. Any thermometerproduct not meeting this requirement shall be marked on asuitable packaging unit or other labeling of the thermometerswith a cautioning statement indicating the ambient temperaturerange in which it can be used with specified ac
19、curacy.5.6 GraduationThe thermometer shall be graduated inintervals no greater than 0.1 C (0.2 F). As a minimum,appropriate numerals shall be placed at every degree gradua-tion for Celsius scale thermometers and at every even degreegraduation for Fahrenheit scale thermometers.5.7 WorkmanshipThere sh
20、all be no constructional defectsthat would prevent the measurement of temperature within theaccuracy requirements of 5.3.5.8 StabilityThermometers shall meet all requirements ofthis specification over their shelf life. If the shelf life of theproduct is less than 5 years when stored in compliance wi
21、th themanufacturers instructions, an uncoded expiration date shallbe displayed on the labeling of the product.5.9 Storage EnvironmentWhen tested in accordance with6.4, thermometers shall meet the requirements of 5.3 after theyhave been stored for 1 day at any point in an environment of18 to 38 C (0
22、to 100 F) and at relative humidities from 15to 90 %. When tested in accordance with 6.4, thermometersshall also meet the requirements of 5.3 after they have beenstored for 1 month at any point in an environment of 15.5 to 32C (60 to 90 F) and 30 to 75 % relative humidity. Anythermometer product not
23、meeting this requirement shall bemarked on a suitable packaging unit or other labeling of thethermometers with a cautioning statement indicating the stor-age temperature range that is applicable.5.10 Marking and Labeling:5.10.1 IdentificationSuitable packaging units of the ther-mometers shall bear i
24、n legible characters the name or trade-mark, or both, of the manufacturer or distributor and adesignation, either a serial number or a code, to indicate thespecific manufacturing lot. Suitable packaging units and otherlabeling shall also bear a statement that the thermometers areintended for single
25、use only.5.10.2 Operating InstructionsOperating instructions mustbe provided. When space limitations dictate, the operatinginstructions on an individual thermometer may be omitted ifdetailed instructions are provided on or with a suitable pack-aging unit.5.10.3 Additional Marking and Labeling Additi
26、onalmarking and labeling that may be required by 5.2, 5.5, 5.8, 5.9,and 6.2.3 shall be clear, concise, and adequate for the intendedpurpose. The temperature measurement offset shall be includedin the labeling of the thermometers.5.11 ToxicityWhen the thermometer is used as specifiedby the manufactur
27、er, its parts intended for contact withanatomical sites during patient use and its melting pointchemicals shall be nontoxic as determined by 6.5.6. Test Methods for Performance Verification6.1 Significance and UseThis section describes the prin-ciples, apparatus, and procedures to be used to determi
28、ne theconformance of disposable thermometers to the requirementsof this specification. Each manufacturer or distributor whorepresents his products as conforming to this specification mayuse statistically based sampling plans that are appropriate. Heshall keep such essential records as are necessary
29、to documenthis claim that all the requirements of this specification are met.This section does not include any procedure for requirementsthat can be verified by visual inspection (such as 5.2).6.2 Accuracy Test:6.2.1 Test Equipment RequiredThe test equipment shallinclude constant-temperature water b
30、aths, the temperatures ofwhich are uniform and are known to be within 60.03 C(60.05 F), as measured by a thermometer or thermometrysystem for which the temperature calibration is traceable to theInternational Temperature Scale of 1990 (ITS-90) as main-tained by the National Institute of Standards an
31、d Technology(NIST) or other appropriate National Standards Laboratory.The volume of each bath shall be a minimum of 1 L.6.2.2 ProcedureInsert the thermometers into the waterbath and test in accordance with the manufacturers specifiedprocedures. Use at least 20 points distributed throughout thetemper
32、ature range on the scale of the thermometer for obtain-ing data. Do not use a given thermometer for obtaining morethan one datum point.6.2.3 SamplingStatistically based sampling of manufac-turing lots is required for the determination of accuracybecause of the destructive nature of the test as appli
33、ed to adisposable thermometer. Use a minimum of 200 measurementsin the accuracy determination for a manufacturing lot with notfewer than 10 measurements at a specified temperature. Thecriteria for lot acceptance shall be stated by the manufacturer inhis literature (labeling).TABLE 1 Accuracy of Ther
34、mometers With a Celsius ScaleTemperature Range, C Maximum Error, CBelow 35.8 60.335.8 to 36.9 60.237.0 to 39.0 60.139.1 to 41.0 60.2Above 41.0 60.3TABLE 2 Accuracy of Thermometers With a Fahrenheit ScaleTemperature Range, F Maximum Error, FBelow 98 60.498 to 102 60.2Above 102 60.4E 825 98 (2009)26.2
35、.4 Measurement Retention TestTest the thermometersin accordance with 6.2.2 and read. One minute later, read thethermometers again. They shall meet the requirements of 5.3.6.3 Operating Environment TestUse this test to determinethe compliance of thermometers to the requirement of 5.5.6.3.1 Test Equip
36、ment RequiredConstant-temperature wa-ter baths (6.2.1); a forced-circulation air oven capable ofheating thermometer samples to 32 6 1C(906 2 F); arefrigerated chamber capable of cooling thermometer sam-plings to 19.0 6 1C(666 2 F). The oven and refrigeratedchamber must be located in close proximity
37、to 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 90 F), for atleast 1 h. Transfer thermometers for testing at any specific bathtemperature, handlin
38、g as in normal use, and insert into the testwater bath within 10 s of removal from either the 32 C ovenor the 19 C chamber and complete the accuracy test inaccordance with 6.2.2.NOTE 3If an environmental test chamber of sufficient size is availablein which the test water baths can be set up without
39、loss of bath temperaturecontrol, it may be used in place of the oven and refrigerated chamber.6.4 Storage Environment TestUse this test to determinethe compliance of thermometers to the requirements of 5.9.6.4.1 Test Equipment RequiredThe constant-temperaturewater baths from 6.2.1 and an environment
40、al test chambercapable of producing environments of 20 6 2C(46 4 F)at 15 to 90 % relative humidities and 38 6 3 C (100 6 5 F)at 30 to 75 % relative humidities are required. Humidityconditions should be made uniform and reproducible. Analternative procedure, requiring less sophisticated facilities, i
41、sto store disposable thermometers for the times and tempera-tures required in 5.9 in closed chambers with humiditiestherein obtained through the use of saturated solutions ofcommon salts or deionized water as indicated in Table 3.6.4.2 ProcedureSubject unopened storage packages to thefour extreme co
42、mbinations of temperature and relative humid-ity indicated in 5.9. Hold them at these conditions for the timeperiods indicated (1 day and 1 month). Remove the sampleswith their packaging unit intact from the test chambers andallow 24 h for the product to return to its operating environ-ment (5.5). T
43、hen remove the thermometers from their packag-ing and complete the accuracy test in accordance with 6.2.2.6.5 Toxicity Tests:6.5.1 Toxicity Test (Extract)Place 100 samples in 100 mLof a 0.85 g % NaCl solution in an oven at 45 C for a periodof time equal to 100 times the manufacturers recommendedpati
44、ent measurement time (3.2.3).After the thermometers havebeen in the solution for the proper length of time at 45 C,perform the following tests on the resulting solution (contain-ing any extracts from the thermometers).6.5.1.1 Acute oral toxicity in rats (10 mL/kg of bodyweight).6.5.1.2 Rabbit eye ir
45、ritation test, National Formulary XIII.6.5.1.3 Primary skin irritation, Code of Federal Regulations,Title 21, Section 191, II, 1971. The thermometers will beconsidered nontoxic if the extract produces reactions notsignificantly different from a blank (saline) sample.6.5.2 Toxicity Test (Chemical Ing
46、estion) Remove theentire melting point chemical contents of one thermometerfrom a thermometer. Divide the weight of these chemicals by25 kg (weight of a human child) to calculate the dosage perkilogram of body weight. Increase this dosage level 100 timesand orally feed in proportion to their body we
47、ight to 10 fasting100-g rats. Observe the rats for 14 days and compare theirreactions to 10 control group rats (not fed the chemicals). If,after 14 days, there is no death or retardation in the dosed ratsas compared to control animals, the melting point chemicalsare considered nontoxic.6.6 Precision
48、 and BiasAll test equipment specified in6.2.1 shall be sufficiently accurate so that test results producedwith the equipment have an expanded uncertainty (k=3) notexceeding 0.045 C.7. Identification7.1 In order that purchasers may identify products conform-ing to all requirements of this specificati
49、on, producers anddistributors may include a statement of compliance 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:7.1.1 “This thermometer conforms to all of the requirementsestablished in ASTM Standard E 825. Full responsibility forthe conformance of this product to the specification is assumedby (name and address of producer or distributor).”7.2 The following abbreviated state
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