1、Designation: E667 98 (Reapproved 2009)Standard Specification forMercury-in-Glass, Maximum Self-Registering ClinicalThermometers1This standard is issued under the fixed designation E667; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revisio
2、n, 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 Defense.1. Scope1.1 This specification cov
3、ers mercury-in-glass, reusablemaximum self-registering clinical thermometers of the typescommonly used for measuring body temperatures of humansand of animals. Requirements are given for bulb and stemglasses, mercury, legibility and permanency of markings,dimensions, temperature scale ranges, and gr
4、aduations, as wellas for thermometer stability, ease of resetting, retention oftemperature indication, and for accuracy of scale reading.Appropriate methods of testing to determine compliance areprovided. Also included is a glossary of terms used in thestandard and an appendix with additional inform
5、ation onthermometer glasses and stability.1.2 All values of temperature in this standard are withreference to the International Temperature Scale of 1990.1.3 This specification was developed to provide nationallyrecognized marketing classifications and quality requirementsfor mercury-in-glass, maxim
6、um self-registering clinical ther-mometers. It is also intended to provide producers, distributors,and users with a common understanding of the characteristicsof this product.1.4 The following precautionary statement pertains only tothe test method portion, Section 6 of this specification: Thisstand
7、ard 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 safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM
8、 Standards:2E29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE344 Terminology Relating to Thermometry and Hydrom-etry3. Terminology3.1 DefinitionsThe definitions given in TerminologyE344 apply to this specification.3.2 Definitions of Terms Specific to
9、 This Standard:3.2.1 bore, nhole or lumen in the stem.3.2.2 calibration date, ndate on which the scale is affixedto a thermometer.3.2.3 ceramic marking, nmarking produced by fusing aceramic colorant onto the glass surface.3.2.4 constriction, nobstruction in the bore of a clinicalthermometer which pe
10、rmits the passage of mercury from thebulb when the bulb is heated, but which restricts its passageback to the bulb when heat is removed.3.2.5 fire cracks, ncracks in glass caused by local tem-perature shock.3.2.6 flat magnifying lens, nthermometer stem glass inwhich the numerals, graduations, and le
11、ns lie on the samerelative surface.3.2.6.1 DiscussionIt is so named for its approximately flatcross section (See Fig. 1.)3.2.7 fractures, ninternal or external breaks or cracks inthe glass.3.2.7.1 DiscussionInternal fractures usually occur in thearea between the bulb and the constriction.3.2.8 gradu
12、ations, nseries of lines on the stem of thethermometer that designate the temperature scale intervals.3.2.9 hard shaker thermometer, nthermometer in whichthe constriction is overly severe thereby restricting the passageof mercury back to the bulb causing the thermometer to fail theease-of-resetting
13、requirements.3.2.10 index, nupper point of the mercury column whoseposition, when noted with respect to the corresponding numer-als and graduations, indicates the temperature of the mercurywithin the bulb.1This specification is under the jurisdiction of ASTM Committee E20 onTemperature Measurement a
14、nd is the direct responsibility of E20.08 on MedicalThermometry.Current edition approved Oct. 15, 2009. Published December 2009. Originallyapproved in 1979. Last previous edition approved in 2003 as E667 98(2003). DOI:10.1520/E0667-98R09.2For referenced ASTM standards, visit the ASTM website, www.as
15、tm.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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.11 m
16、agnifying lens, nstem glass that, due to itsconfiguration, results in a magnification of the mercury col-umn.3.2.12 normal human temperature, nconventionally ac-cepted average body temperature in healthy human beings(37 C or 98.6 F).3.2.13 ovulation thermometer, nthermometer specificallydesigned for
17、 obtaining body temperature for the purpose ofdetermining the date of ovulation or the basal body tempera-ture.3.2.14 reflecting stem, nstem glass containing a coloredstripe along its length in a location that, when reflected on themercury column, allows greater contrast and enables thecolumn to app
18、ear tinted.3.2.15 residual mercury column, nmercury that lies in thebore of the stem above the constriction.3.2.16 retreating index thermometer, nthermometer inwhich the constriction is not sufficiently small to prevent thepassage of mercury back to the bulb (or the mercury indexfrom falling) withou
19、t shaking when heat is removed from thebulb.3.2.17 scale range, nrange of temperature through whicha thermometer is usable.3.2.18 stained marking, nmarking produced by diffusingcolorant into the glass surface.3.2.19 subnormal thermometer, nclinical thermometerspecifically designed for obtaining lowe
20、r than normal bodytemperatures.3.2.19.1 DiscussionA subnormal thermometer is markedwith a subnormal scale range. See 4.4.3.2.20 triangular magnifying lens, nthermometer stemglass in which the numerals and graduations lie on surfaces thatsmoothly merge to form a lens.3.2.20.1 DiscussionIt is so named
21、 for its approximatelytriangular cross section. (See Fig. 1.)4. Classification4.1 Clinical thermometers covered by these specificationsare generally available in the following classifications. Otherdesigns and configurations of thermometers meeting the re-quirements specified herein shall also be co
22、nsidered as com-plying with this specification.NOTE 1The requirements of this specification shall not preclude themanufacture and sale of special thermometers having different tempera-ture ranges and degrees of subdivision designed for specific medical uses.Packaging on any “special” thermometers sh
23、all 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 such a way so as to identify it as “special.”4.2 TypesThermometers are classified by types as foll
24、ows(see Fig. 2):4.2.1 Human:4.2.1.1 Basal or Ovulation, with large cylindrical bulb(ovulation scale).4.2.1.2 Multiuse (Oral or Rectal ), with stubby bulb (regularscale).4.2.1.3 Oral, with cylindrical bulb (regular scale).4.2.1.4 Rectal, with pear shaped bulb (regular scale).4.2.1.5 Subnormal4.2.2 Ve
25、terinary:Cross section of magnifying lens stems.FIG. 1 Composite and Sectional Views of Clinical Thermometers (These sketches are for illustration only.)E667 98 (2009)24.2.2.1 Ring Top, 100-mm (4 in.), with stubby bulb (regularscale).4.2.2.2 Heavy Duty Ring Top, 125-mm (5 in.) with stubbybulb (exten
26、ded scale).4.3 StemsThermometer stems are classified as follows(see Fig. 2):4.3.1 Flat magnifying lens.4.3.2 Triangular reflecting magnifying lens.4.3.3 Triangular magnifying lens.4.4 ScalesThermometer temperature scales and rangesare classified as follows:4.4.1 Celsius (formerly known as Centigrade
27、):4.4.1.1 Regular Scale, at least 35.5 to 41 C,4.4.1.2 Ovulation Scale, at least 35.5 to 38 C,4.4.1.3 Extended Scale, at least 35.5 to 44 C, and4.4.1.4 Subnormal Scale, at least 21 to 38 C.4.4.2 Fahrenheit (Note 2):4.4.2.1 Regular Scale, at least 96 to 106 F,4.4.2.2 Ovulation Scale, at least 96 to 1
28、00 F,4.4.2.3 Extended Scale, at least 96 to 110 F,4.4.2.4 Subnormal Scale, at least 70 to 100 F.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 sca
29、les forconformance with this specification.4.5 MarkingThermometer markings are classified as fol-lows:4.5.1 Etched and filled.4.5.2 Stained.4.5.3 Ceramic marked.4.5.4 Marked in other ways that meet all of the requirementsof this specification.5. Requirements5.1 GeneralAll thermometers represented as
30、 complyingwith this specification shall meet all of the requirementsspecified herein. Terms shall be as defined in Section 4.5.2 GlassThermometers shall be made from bulb glassand magnifying lens stem glass (glasses) having properties andcharacteristics that ensure stability, accuracy, and reliabili
31、ty inaccordance with the requirements of this specification. (SeeAppendix X1.)5.3 MercuryMercury used in the thermometers shall havethe purity, properties, and characteristics that will enable thefinished thermometers to comply with all the performancerequirements of this specification. In addition,
32、 when finishedthermometers are visually examined, the bulb and the mercurycolumn shall be free of gas or other foreign material.5.4 Fabrication of Regular-Scale Thermometer for HumanUse:5.4.1 LengthThe overall length of the thermometers shallnot be less than 98 mm (378 in.).5.4.2 Thickness of StemNo
33、 dimension of the cross sectionof flat magnifying stems shall be greater than 7.6 mm (0.30 in.)nor less than 3.6 mm (0.14 in.). No dimension of the crosssection of triangular stems shall be less than 3.6 mm (0.14 in.).5.4.3 Scale Range and PositionThere shall not be morethan 5.0 C (9.0 F) per 25.4 m
34、m (1 in.) of temperature scale.The range of scale shall be at least from 35.5 to 41 C (96 to106 F). The 35.5 C (96 F) graduation mark shall not be lessthan 11 mm (716 in.) from the base of the mercury column. The41 C (106 F) mark shall be at least 3 mm (18 in.) from theend of the bore.5.4.4 Celsius
35、GraduationsCelsius thermometers shall begraduated in 0.1 C intervals. All full-degree and half-degreeFIG. 2 Types of Clinical Thermometers (These sketches are for illustration only.)E667 98 (2009)3graduations shall be long lines, and all other graduations shallbe short lines (see 5.4.6).Appropriate
36、numerals shall be placedat every full-degree graduation. If an arrow or other markdesignating normal is used, the numeral at 37 C may beeliminated.5.4.5 Fahrenheit GraduationsFahrenheit thermometersshall be graduated in 0.2 F intervals. All full-degree gradua-tions shall be long lines, and the gradu
37、ation for 98.6 F mayalso be a long line or other suitable mark.All other graduationsshall be short lines (see 5.4.6). Appropriate numerals shall beplaced at every even-degree graduation.5.4.6 Temperature Scale Graduation MarksAll short (0.1and 0.2) graduation lines shall not be less than 1.3 mm (0.0
38、5in.) in length, and all long graduation lines shall be at least25 % longer than the short lines. The graduation lines shall besubstantially straight, uniformly spaced, of uniform width, andshall be perpendicular to the axis of the stem. They shall not bewider than the spaces between the graduations
39、, nor wider than0.46 mm (0.018 in.) and shall not be narrower than 0.10 mm(0.004 in.).5.4.7 Normal Human Temperature MarksThe lines at37 C (98.6 F) may be designated by an arrow or othersuitable mark. If used, the mark shall be accurately positionedto within a tolerance of 612 of the minimum graduat
40、edinterval.5.4.8 Legibility of Marks, Numbers, and GraduationsAlltemperature scale graduations and numerals and all identifica-tion marks shall be made readily legible by the use of colorant.The cumulative absence of colorant from graduation lines shallnot be more than the equivalent of one long gra
41、duation line, thecumulative absence of colorant from numbers shall not bemore than the equivalent of one entire number, and thecumulative absence of colorant from letters shall not be morethan the equivalent of one complete letter.5.4.9 Permanency of Marks, Numbers, and GraduationsWhen tested in acc
42、ordance with 6.2, all temperature scalegraduations and numerals and all identification marks shall notfade or discolor in such a manner as to impair their legibility.The cumulative absence of colorant from graduation lines shallnot be more than the equivalent of one long graduation line, thecumulati
43、ve absence of colorant from numbers shall not bemore than the equivalent of one entire number, and thecumulative absence of colorant from letters shall not be morethan the equivalent of one complete letter.5.4.10 StabilityThermometers shall be stabilized by natu-ral or artificial means to assure tha
44、t the requirements of thisspecification will be maintained by the thermometers while innormal use (see Appendix X1).5.4.11 AccuracyNo individual reading on any non-specialscale thermometer shall be in error by more than the followingin the ranges indicated:Celsius Scale, C Fahrenheit Scale, FRangeMa
45、xi-mumErrorRangeMaxi-mumErrorLess than 35.8 0.3 Less than 96.4 0.435.8 to less than 37.0 0.2 96.4 to less than 98.0 0.337.0 to 39.0 0.1 98.0 to 102.0 0.2Greater than 39.0 to 41.0 0.2 Greater than 102.0 to 106.0 0.3Greater than 41.0 0.3 Greater than 106.0 0.4Testing shall be in accordance with 6.3. R
46、eadings shall berounded to one decimal place as provided in RecommendedPractice E29.5.4.12 Ease of ResettingThe length of the residual mer-cury column shall not exceed 20.6 mm (1316 in.), and the top ofthe column shall fall below 35.5 C (96 F) when tested inaccordance with 6.4 (See description of ha
47、rd shaker thermom-eter in 3.2.9.)5.4.13 Temperature RetentionEach thermometer shall in-dicate 41.0 6 0.2 C (106.0 6 0.3 F) when tested in accor-dance with 6.5. If applicable, as provided in 6.3, the acceptableindication shall be 40.8 6 0.2 C (105.6 6 0.3 F). (Seedescription of retreating index therm
48、ometer in 3.2.16.)5.4.14 WorkmanshipThere shall be no constructional de-fects that would prevent the observations of temperature. Thepresence of unhealed fire cracks or fractures, when tested inaccordance with 6.6, shall be considered evidence of discred-itable workmanship.5.5 Fabrication of Ovulati
49、on-Scale ThermometersThermometers designed for use in determining the date ofovulation or the basal body temperature shall meet the preced-ing requirements with the following exceptions:5.5.1 Scale Range and PositionThere shall not be morethan 3 C (4 F) per 38 mm (112 in.) of temperature scale. Therange of the scale shall be at least from 35.5 to 38 C (96 to100 F) as applicable. The 38 C (100 F) graduation markshall be at least 3 mm (18 in.) from the end of the bore.5.5.2 Temperature Sc
