1、Designation: E667 98 (Reapproved 2017)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.1. Scope1.1 This specification covers mercury-in-glass, reusablemaximum self-registering clinical thermometers of t
3、he 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 graduations, as wellas for thermometer stability, ease of resetting, retention ofte
4、mperature 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 information onthermometer glasses and stability.1.2 All values of temperature in this s
5、tandard 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, maximum self-registering clinical ther-mometers. It is also intended to provide produc
6、ers, 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: Thisstandard does not purport to address all of the safety concerns,if any, associated wit
7、h its use. It is the responsibility of the userof this standard to establish appropriate safety, health, andenvironmental practices and determine the applicability ofregulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized princ
8、iples on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E29 Practice for Using Significa
9、nt Digits in Test Data toDetermine Conformance with SpecificationsE344 Terminology Relating to Thermometry and Hydrom-etry3. Terminology3.1 DefinitionsThe definitions given in Terminology E344apply to this specification.3.2 Definitions of Terms Specific to This Standard:3.2.1 bore, nhole or lumen in
10、 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 permits the passage of mercury from thebulb wh
11、en 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 lens lie on the samerelative surface.3.2.6.1 D
12、iscussionIt 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 graduations, nseries of lines on the stem of thet
13、hermometer that designate the temperature scale intervals.3.2.9 hard shaker thermometer, nthermometer in whichthe constriction is overly severe thereby restricting the passage1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the d
14、irect responsibility ofF04.33 on Medical/Surgical Instruments.Current edition approved Dec. 15, 2017. Published January 2018. Originallyapproved in 1979. Last previous edition approved in 2009 as E667 98(2009). DOI:10.1520/E0667-98R17.2For referenced ASTM standards, visit the ASTM website, www.astm.
15、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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis internat
16、ional standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Commit
17、tee.1of mercury back to the bulb causing the thermometer to fail theease-of-resetting 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.3.2.11 ma
18、gnifying 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
19、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 appe
20、ar 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) without
21、 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 lower
22、 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
23、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 con
24、sidered 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 sha
25、ll 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.”Cross section of magnifying lens stems.FIG. 1 Composit
26、e and Sectional Views of Clinical Thermometers (These sketches are for illustration only.)E667 98 (2017)24.2 TypesThermometers are classified by types as follows(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 s
27、tubby 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 Subnormal.4.2.2 Veterinary:4.2.2.1 Ring Top, 100-mm (4 in.), with stubby bulb (regularscale).4.2.2.2 Heavy Duty Ring Top, 125-mm (5 in.) with stubbybulb (extend
28、ed 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 ranges areclassified as follows:4.4.1 Celsius (formerly known as Centigrade)
29、: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 10
30、0 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 scal
31、es 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
32、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 reliabilit
33、y 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,
34、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.).FIG. 2 Types of Clinical T
35、hermometers (These sketches are for illustration only.)E667 98 (2017)35.4.2 Thickness of StemNo 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 m
36、m (0.14 in.).5.4.3 Scale Range and PositionThere shall not be morethan 5.0 C (9.0 F) per 25.4 mm (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 colu
37、mn. The41 C (106 F) mark shall be at least 3 mm (18 in.) from theend of the bore.5.4.4 Celsius GraduationsCelsius thermometers shall begraduated in 0.1 C intervals. All full-degree and half-degreegraduations shall be long lines, and all other graduations shallbe short lines (see 5.4.6).Appropriate n
38、umerals 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 gradua
39、tion 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 (0.05
40、in.) 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,
41、 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 graduate
42、dinterval.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 grad
43、uation 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 acco
44、rdance 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, thecumulativ
45、e 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 that
46、 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, FRangeMax
47、i-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. Re
48、adings 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 har
49、d 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 thermometer 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 inaccordan
