ASTM E667-1998(2003) Standard Specification for Mercury-in-Glass Maximum Self-Registering Clinical Thermometers《温度计(自动记录最高温度水银玻璃温度计)》.pdf

1、Designation: E 667 98 (Reapproved 2003)Standard Specification forMercury-in-Glass, Maximum Self-Registering ClinicalThermometers1This standard is issued under the fixed designation E 667; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revis

2、ion, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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

3、covers 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

4、 graduations, 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 inf

5、ormation 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, ma

6、ximum 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: Thisst

7、andard 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 A

8、STM Standards:E 29 Practice for Using Significant Digits in Test Data toDetermine Conformance with Specifications2E 344 Terminology Relating to Thermometry and Hydrom-etry33. Terminology3.1 DefinitionsThe definitions given in TerminologyE 344 apply to this specification.3.2 Definitions of Terms Spec

9、ific to 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 w

10、hich permits 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,

11、 and lens 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.

12、8 graduations, 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-res

13、etting 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 Measur

14、ement and is the direct responsibility of E20.08 on MedicalThermometry.Current edition approved May 10, 2003. Published July 2003. Originallyapproved in 1979. Last previous edition approved in 1998 as E 667 98.2Annual Book of ASTM Standards, Vol 14.02.3Annual Book of ASTM Standards, Vol 14.03.1Copyr

15、ight ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.11 magnifying 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 te

16、mperature in healthy human beings(37 C or 98.6 F).3.2.13 ovulation thermometer, nthermometer specificallydesigned for 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

17、 length in a location that, when reflected on themercury column, allows greater contrast and enables thecolumn to appear 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

18、is not sufficiently small to prevent thepassage of mercury back to the bulb (or the mercury indexfrom falling) without 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 diffusingcolora

19、nt into the glass surface.3.2.19 subnormal thermometer, nclinical thermometerspecifically designed for obtaining lower 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 w

20、hich the numerals and graduations lie on surfaces thatsmoothly merge to form a lens.3.2.20.1 DiscussionIt is so named for its approximatelytriangular cross section. (See Fig. 1.)4. Classification4.1 Clinical thermometers covered by these specificationsare generally available in the following classif

21、ications. Otherdesigns and configurations of thermometers meeting the re-quirements specified herein shall also be considered as com-plying with this specification.NOTE 1The requirements of this specification shall not preclude themanufacture and sale of special thermometers having different tempera

22、-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 compliance with this specification. In addition, the special thermomete

23、rmust be marked in such a way so as to identify it as “special.”4.2 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 stubby bulb (regularscale).4.2.1.3 Oral,

24、with cylindrical bulb (regular scale).4.2.1.4 Rectal, with pear shaped bulb (regular scale).4.2.1.5 Subnormal4.2.2 Veterinary:Cross section of magnifying lens stems.FIG. 1 Composite and Sectional Views of Clinical Thermometers (These sketches are for illustration only.)E 667 98 (2003)24.2.2.1 Ring T

25、op, 100-mm (4 in.), with stubby bulb (regularscale).4.2.2.2 Heavy Duty Ring Top, 125-mm (5 in.) with stubbybulb (extended 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.

26、4 ScalesThermometer temperature scales and rangesare classified as follows:4.4.1 Celsius (formerly known as Centigrade):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 t

27、o 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 100 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 ar

28、e not necessarily exact Celsius conversions but are thevalues to be used when testing thermometers with Fahrenheit scales 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

29、 ways that meet all of the requirementsof this specification.5. Requirements5.1 GeneralAll thermometers represented as 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 ma

30、gnifying lens stem glass (glasses) having properties andcharacteristics that ensure stability, accuracy, and reliability inaccordance with the requirements of this specification. (SeeAppendix X1.)5.3 MercuryMercury used in the thermometers shall havethe purity, properties, and characteristics that w

31、ill enable thefinished thermometers to comply with all the performancerequirements of this specification. In addition, 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 Human

32、Use:5.4.1 LengthThe overall length of the thermometers shallnot be less than 98 mm (378 in.).5.4.2 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 s

33、hall 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 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 b

34、ase 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 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.)

35、E 667 98 (2003)3graduations shall be long lines, and all other graduations shallbe short lines (see 5.4.6). Appropriate 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 GraduationsFahre

36、nheit thermometersshall be graduated in 0.2 F intervals. All full-degree gradua-tions shall be long lines, and the graduation 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 grad

37、uation.5.4.6 Temperature Scale Graduation MarksAll short (0.1and 0.2) graduation lines shall not be less than 1.3 mm (0.05in.) 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

38、 width, andshall be perpendicular to the axis of the stem. They shall not bewider than the spaces between the graduations, 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 o

39、r othersuitable mark. If used, the mark shall be accurately positionedto within a tolerance of 612 of the minimum graduatedinterval.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

40、of colorant.The cumulative absence of colorant from graduation lines shallnot be more than the equivalent of one long graduation 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 no

41、t be morethan the equivalent of one complete letter.5.4.9 Permanency of Marks, Numbers, and GraduationsWhen tested in accordance 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 cumulativ

42、e absence of colorant from graduation lines shallnot be more than the equivalent of one long graduation 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 equival

43、ent of one complete letter.5.4.10 StabilityThermometers shall be stabilized by natu-ral or artificial means to assure that 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 th

44、ermometer shall be in error by more than the followingin the ranges indicated:Celsius Scale, C Fahrenheit Scale, FRangeMaxi-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

45、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. Readings shall berounded to one decimal place as provided in RecommendedPractice E 29.5.4.12 Ease of ResettingThe length of the residual mer-cury column shall not exceed 20.6 mm (1

46、316 in.), and the top ofthe column shall fall below 35.5 C (96 F) when tested inaccordance with 6.4 (See description of hard 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

47、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

48、, when tested inaccordance with 6.6, shall be considered evidence of discred-itable workmanship.5.5 Fabrication of Ovulation-Scale ThermometersThermometers designed for use in determining the date ofovulation or the basal body temperature shall meet the preced-ing requirements with the following exc

49、eptions: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 Scale GraduationsThermometers shallbe graduated in intervals no greater than 0.05 C (0.1 F). Allfull-degree and half-degree graduations shall be long lines, andall other graduation