1、Designation: E825 98 (Reapproved 2016)Standard Specification forPhase Change-Type Disposable Fever Thermometer forIntermittent Determination of Human Temperature1This standard is issued under the fixed designation E825; 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 phase change-type clinicalthermometers that
3、 are designed and intended for one-time use.2. Referenced Documents2.1 ASTM Standards:2E344 Terminology Relating to Thermometry and Hydrom-etry2.2 Other Standards:National Formulary, Volume XIII Code of FederalRegulations, Title 21, Section 191, II 1971.3. Terminology3.1 DefinitionsThe definitions g
4、iven in Terminology E344apply.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 of entirely separate measurements.3.2.2 manufacturing lot, nin the case of a continuous
5、manufacturing 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 batch process, a lot means a batchor specific identified portion of a batch having unifo
6、rmcharacter 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.3.2.4 predictive thermometer, nany thermometer that pro-vides an indication of the final
7、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 themanufacturer for long-term storage at the users facility.3.2.6 suitable packaging unit,
8、 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 finaluser.3.2.7 temperature offset, ndesigned difference in predic-tive thermometer readings an
9、d 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 themanufacture and sale of special thermometers having different tempera-ture ranges and d
10、egrees 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 compliance with this specification. In addition, the special thermometermust be marked in
11、 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 are thevalues to be used when testing thermometers with Fahrenheit scales forconformance
12、 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 3.5.2 Temperature RangeThe instrument shall cover theminimum range from 35 to 40.4 C (96 to 104.8 F) un
13、lessotherwise obviously labeled. If any thermometer does not meetthe range 35 to 40.4 C (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 a
14、ccor-dance with 6.2 at any point on the temperature scale of thethermometer.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
15、 Oct. 1, 2016. Published October 2016. Originallyapproved in 1981. Last previous edition approved in 2009 as E825 09. DOI:10.1520/E0825-98R16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vol
16、ume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.4 Measurement RetentionA measurement meeting theaccuracy requirements of 5.3 will be maintained for a m
17、ini-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 in accordance with6.3, shall meet the requirements of 5.3. Any thermometerproduct not meeting
18、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 accuracy.5.6 GraduationThe thermometer shall be graduated inintervals no greater than 0.1 C (0.
19、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 shall be no constructional defectsthat would prevent the measurement of temperature within thea
20、ccuracy 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 with themanufacturers instructions, an uncoded expiration date shallbe displayed on the labelin
21、g 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 to 100 F) and at relative humidities from 15to 90 %. When tested in accordance with 6.4, ther
22、mometersshall 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 meeting this requirement shall bemarked on a suitable packaging unit or other labeling of the
23、thermometers 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 in legible characters the name ortrademark, or both, of the manufacturer or distributor and ad
24、esignation, 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 use only.5.10.2 Operating InstructionsOperating instructions mustbe provided. When space limita
25、tions 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 LabelingAdditional mark-ing and labeling that may be required by 5.2, 5.5, 5.8, 5.9, and6.2.3 shall be clear,
26、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 manufacturer, its parts intended for contact withanatomical sites during patient use and its melting poi
27、ntchemicals shall be nontoxic as determined by 6.5.6. Test Methods for Performance Verification6.1 Significance and UseThis section describes theprinciples, apparatus, and procedures to be used to determinethe conformance of disposable thermometers to the require-ments of this specification. Each ma
28、nufacturer or distributorwho represents his products as conforming to this specificationmay use statistically based sampling plans that are appropriate.He shall keep such essential records as are necessary todocument his claim that all the requirements of this specifica-tion are met. This section do
29、es not include any procedure forrequirements that can be verified by visual inspection (such as5.2).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 me
30、asured 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 and Technology(NIST) or other appropriate National Standards Laboratory.The volume of each bath
31、 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 thetemperature range on the scale of the thermometer for obtain-ing data. Do not use a given thermomet
32、er 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 applied to adisposable thermometer. Use a minimum of 200 measurementsin the accuracy determination
33、 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).6.2.4 Measurement Retention TestTest the thermometersin accordance with 6.2.2 and read. One minute later, read thethe
34、rmometers 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.TABLE 1 Accuracy of Thermometers With a Celsius ScaleTemperature Range, C Maximum Error, CBelow 35.8 0.335.8 to 36.9 0.237.0 to 39
35、.0 0.139.1 to 41.0 0.2Above 41.0 0.3TABLE 2 Accuracy of Thermometers With a Fahrenheit ScaleTemperature Range, F Maximum Error, FBelow 98 0.498 to 102 0.2Above 102 0.4E825 98 (2016)26.3.1 Test Equipment RequiredConstant-temperature wa-ter baths (6.2.1); a forced-circulation air oven capable ofheatin
36、g 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 to the constant-temperature water baths.6.3.2 ProcedureEquilibrate samples of thermometers inan immedi
37、ate 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, handling as in normal use, and insert into the testwater bath within 10 s of removal from either the 32 C ove
38、nor the 19 C chamber and complete the accuracy test inaccordance with 6.2.2.NOTE 3If an environmental test chamber of sufficient size that the testwater baths can be set up without loss of bath temperature control isavailable, it may be used in place of the oven and refrigerated chamber.6.4 Storage
39、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 environmental test chambercapable of producing environments of 20 6 2C(46 4 F)at 15 to 90 % relative humidities and 3
40、8 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, isto store disposable thermometers for the times and tempera-tures required in 5.9 in closed chambers with
41、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 combinations of temperature and relative humid-ity indicated in 5.9. Hold them at these conditions for the t
42、imeperiods 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). Then remove the thermometers from their packag-ing and complete the accuracy test in accordance with 6.2.2.
43、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 recommendedpatient measurement time (3.2.3).After the thermometers havebeen in the solution for the proper length of time
44、 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 irritation test, National Formulary XIII.6.5.1.3 Primary skin irritation, Code of Federal Regulations,Title
45、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 Ingestion)Remove the entiremelting point chemical contents of one thermometer from athermometer. Divide the w
46、eight of these chemicals by 25 kg(weight of a human child) to calculate the dosage per kilogramof body weight. Increase this dosage level 100 times and orallyfeed in proportion to their body weight to 10 fasting 100-g rats.Observe the rats for 14 days and compare their reactions to 10control group r
47、ats (not fed the chemicals). If, after 14 days,there is no death or retardation in the dosed rats as comparedto control animals, the melting point chemicals are considerednontoxic.6.6 Precision and BiasAll test equipment specified in6.2.1 shall be sufficiently accurate so that test results producedw
48、ith 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 specification, producers anddistributors may include a statement of compliance in conjunc-tion with their name and add
49、ress 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 inASTM Standard E825. Full responsibility for theconformance of this product to the specification is assumed by(name and address of producer or distributor).”7.2 The following abbreviated statement is suggested whenavailable space on labels is insufficient for the full statement:7.2.1 “Conforms
