ASTM E667-98(2003)
(Specification)Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
ABSTRACT
This specification covers mercury-in-glass, reusable maximum self-registering clinical thermometers of the types commonly used for measuring body temperatures of humans and of animals. Clinical thermometers shall be classified as follows: basal metabolism or ovulation; multi-use with stubby bulb; oral; rectal; veterinary; and veterinary (heavy duty). The following tests shall be performed to conform to the specified requirements: retention of colorant; accuracy test; ease of resetting; temperature retention; fire cracks; and precision and bias.
SCOPE
1.1 This specification covers mercury-in-glass, reusable maximum self-registering clinical thermometers of the types commonly used for measuring body temperatures of humans and of animals. Requirements are given for bulb and stem glasses, mercury, legibility and permanency of markings, dimensions, temperature scale ranges, and graduations, as well as for thermometer stability, ease of resetting, retention of temperature indication, and for accuracy of scale reading. Appropriate methods of testing to determine compliance are provided. Also included is a glossary of terms used in the standard and an appendix with additional information on thermometer glasses and stability.
1.2 All values of temperature in this standard are with reference to the International Temperature Scale of 1990.
1.3 This specification was developed to provide nationally recognized marketing classifications and quality requirements for mercury-in-glass, maximum self-registering clinical thermometers. It is also intended to provide producers, distributors, and users with a common understanding of the characteristics of this product.
1.4 The following precautionary statement pertains only to the test method portion, Section 6 of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E667 – 98 (Reapproved 2003)
Standard Specification for
Mercury-in-Glass, Maximum Self-Registering Clinical
Thermometers
This standard is issued under the fixed designation E667; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript 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. Scope E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers mercury-in-glass, reusable
E344 Terminology Relating to Thermometry and Hydrom-
maximum self-registering clinical thermometers of the types
etry
commonly used for measuring body temperatures of humans
and of animals. Requirements are given for bulb and stem
3. Terminology
glasses, mercury, legibility and permanency of markings,
3.1 Definitions—The definitions given in Terminology
dimensions, temperature scale ranges, and graduations, as well
E344 apply to this specification.
as for thermometer stability, ease of resetting, retention of
3.2 Definitions of Terms Specific to This Standard:
temperature indication, and for accuracy of scale reading.
3.2.1 bore, n—hole or lumen in the stem.
Appropriate methods of testing to determine compliance are
3.2.2 calibration date, n—date on which the scale is affixed
provided. Also included is a glossary of terms used in the
to a thermometer.
standard and an appendix with additional information on
3.2.3 ceramic marking, n—marking produced by fusing a
thermometer glasses and stability.
ceramic colorant onto the glass surface.
1.2 All values of temperature in this standard are with
3.2.4 constriction, n—obstruction in the bore of a clinical
reference to the International Temperature Scale of 1990.
thermometer which permits the passage of mercury from the
1.3 This specification was developed to provide nationally
bulb when the bulb is heated, but which restricts its passage
recognized marketing classifications and quality requirements
back to the bulb when heat is removed.
for mercury-in-glass, maximum self-registering clinical ther-
3.2.5 fire cracks, n—cracks in glass caused by local tem-
mometers.Itisalsointendedtoprovideproducers,distributors,
perature shock.
and users with a common understanding of the characteristics
3.2.6 flat magnifying lens, n—thermometer stem glass in
of this product.
which the numerals, graduations, and lens lie on the same
1.4 The following precautionary statement pertains only to
relative surface.
the test method portion, Section 6 of this specification: This
3.2.6.1 Discussion—Itissonamedforitsapproximatelyflat
standard does not purport to address all of the safety concerns,
cross section (See Fig. 1.)
if any, associated with its use. It is the responsibility of the user
3.2.7 fractures, n—internal or external breaks or cracks in
of this standard to establish appropriate safety and health
the glass.
practices and determine the applicability of regulatory limita-
3.2.7.1 Discussion—Internal fractures usually occur in the
tions prior to use.
area between the bulb and the constriction.
2. Referenced Documents 3.2.8 graduations, n—series of lines on the stem of the
thermometer that designate the temperature scale intervals.
2.1 ASTM Standards:
3.2.9 hard shaker thermometer, n—thermometer in which
the constriction is overly severe thereby restricting the passage
This specification is under the jurisdiction of ASTM Committee E20 on
ofmercurybacktothebulbcausingthethermometertofailthe
Temperature Measurement and is the direct responsibility of E20.08 on Medical
ease-of-resetting requirements.
Thermometry.
Current edition approved May 10, 2003. Published July 2003. Originally
approved in 1979. Last previous edition approved in 1998 as E667–98. DOI:
10.1520/E0667-98R03.
2 3
Annual Book of ASTM Standards, Vol 14.02. Annual Book of ASTM Standards, Vol 14.03.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E667 – 98 (2003)
Cross section of magnifying lens stems.
FIG. 1 Composite and Sectional Views of Clinical Thermometers (These sketches are for illustration only.)
3.2.10 index, n—upper point of the mercury column whose 3.2.19 subnormal thermometer, n—clinical thermometer
position, when noted with respect to the corresponding numer- specifically designed for obtaining lower than normal body
als and graduations, indicates the temperature of the mercury temperatures.
within the bulb. 3.2.19.1 Discussion—A subnormal thermometer is marked
3.2.11 magnifying lens, n—stem glass that, due to its with a subnormal scale range. See 4.4.
configuration, results in a magnification of the mercury col- 3.2.20 triangular magnifying lens, n—thermometer stem
umn. glassinwhichthenumeralsandgraduationslieonsurfacesthat
3.2.12 normal human temperature, n—conventionally ac- smoothly merge to form a lens.
cepted average body temperature in healthy human beings 3.2.20.1 Discussion—It is so named for its approximately
(37°C or 98.6°F). triangular cross section. (See Fig. 1.)
3.2.13 ovulation thermometer, n—thermometer specifically
4. Classification
designed for obtaining body temperature for the purpose of
determining the date of ovulation or the basal body tempera- 4.1 Clinical thermometers covered by these specifications
ture. are generally available in the following classifications. Other
3.2.14 reflecting stem, n—stem glass containing a colored
designs and configurations of thermometers meeting the re-
stripe along its length in a location that, when reflected on the quirements specified herein shall also be considered as com-
mercury column, allows greater contrast and enables the
plying with this specification.
column to appear tinted.
NOTE 1—The requirements of this specification shall not preclude the
3.2.15 residual mercury column, n—mercury that lies in the
manufacture and sale of special thermometers having different tempera-
bore of the stem above the constriction.
ture ranges and degrees of subdivision designed for specific medical uses.
3.2.16 retreating index thermometer, n—thermometer in
Packaging on any “special” thermometers shall state that the thermometer
isaspecialoneintendedforaspecificuseand,therefore,isnotnecessarily
which the constriction is not sufficiently small to prevent the
incompliancewiththisspecification.Inaddition,thespecialthermometer
passage of mercury back to the bulb (or the mercury index
must be marked in such a way so as to identify it as “special.”
from falling) without shaking when heat is removed from the
bulb. 4.2 Types—Thermometersareclassifiedbytypesasfollows
3.2.17 scale range, n—range of temperature through which (see Fig. 2):
a thermometer is usable. 4.2.1 Human:
3.2.18 stained marking, n—marking produced by diffusing 4.2.1.1 Basal or Ovulation, with large cylindrical bulb
colorant into the glass surface. (ovulation scale).
E667 – 98 (2003)
FIG. 2 Types of Clinical Thermometers (These sketches are for illustration only.)
4.2.1.2 Multiuse (Oral or Rectal),withstubbybulb(regular 4.5.1 Etched and filled.
scale). 4.5.2 Stained.
4.2.1.3 Oral, with cylindrical bulb (regular scale). 4.5.3 Ceramic marked.
4.2.1.4 Rectal, with pear shaped bulb (regular scale). 4.5.4 Markedinotherwaysthatmeetalloftherequirements
4.2.1.5 Subnormal of this specification.
4.2.2 Veterinary:
4.2.2.1 Ring Top, 100-mm (4 in.), with stubby bulb (regular 5. Requirements
scale).
5.1 General—All thermometers represented as complying
4.2.2.2 Heavy Duty Ring Top, 125-mm (5 in.) with stubby
with this specification shall meet all of the requirements
bulb (extended scale).
specified herein. Terms shall be as defined in Section 4.
4.3 Stems—Thermometer stems are classified as follows
5.2 Glass—Thermometers shall be made from bulb glass
(see Fig. 2):
andmagnifyinglensstemglass(glasses)havingpropertiesand
4.3.1 Flat magnifying lens.
characteristics that ensure stability, accuracy, and reliability in
4.3.2 Triangular reflecting magnifying lens.
accordance with the requirements of this specification. (See
4.3.3 Triangular magnifying lens.
Appendix X1.)
4.4 Scales—Thermometer temperature scales and ranges
5.3 Mercury—Mercury used in the thermometers shall have
are classified as follows:
the purity, properties, and characteristics that will enable the
4.4.1 Celsius (formerly known as Centigrade):
finished thermometers to comply with all the performance
4.4.1.1 Regular Scale, at least 35.5 to 41°C,
requirements of this specification. In addition, when finished
4.4.1.2 Ovulation Scale, at least 35.5 to 38°C,
thermometers are visually examined, the bulb and the mercury
4.4.1.3 Extended Scale, at least 35.5 to 44°C, and
column shall be free of gas or other foreign material.
4.4.1.4 Subnormal Scale, at least 21 to 38°C.
5.4 Fabrication of Regular-Scale Thermometer for Human
4.4.2 Fahrenheit (Note 2):
Use:
4.4.2.1 Regular Scale, at least 96 to 106°F,
5.4.1 Length—The overall length of the thermometers shall
4.4.2.2 Ovulation Scale, at least 96 to 100°F,
not be less than 98 mm (3 ⁄8 in.).
4.4.2.3 Extended Scale, at least 96 to 110°F,
5.4.2 Thickness of Stem—Nodimensionofthecrosssection
4.4.2.4 Subnormal Scale, at least 70 to 100°F.
offlatmagnifyingstemsshallbegreaterthan7.6mm(0.30in.)
nor less than 3.6 mm (0.14 in.). No dimension of the cross
NOTE 2—The Fahrenheit temperatures given in parentheses throughout
this specification are not necessarily exact Celsius conversions but are the section of triangular stems shall be less than 3.6 mm (0.14 in.).
values to be used when testing thermometers with Fahrenheit scales for
5.4.3 Scale Range and Position—There shall not be more
conformance with this specification.
than 5.0°C (9.0°F) per 25.4 mm (1 in.) of temperature scale.
4.5 Marking—Thermometer markings are classified as fol- The range of scale shall be at least from 35.5 to 41°C (96 to
lows: 106°F). The 35.5°C (96°F) graduation mark shall not be less
E667 – 98 (2003)
than11mm( ⁄16in.)fromthebaseofthemercurycolumn.The
Maxi- Maxi-
Range mum Range mum
41°C (106°F) mark shall be at least 3 mm ( ⁄8 in.) from the
Error Error
end of the bore.
Less than 35.8 0.3 Less than 96.4 0.4
5.4.4 Celsius Graduations—Celsius thermometers shall be
35.8 to less than 37.0 0.2 96.4 to less than 98.0 0.3
graduated in 0.1°C intervals. All full-degree and half-degree
37.0 to 39.0 0.1 98.0 to 102.0 0.2
graduations shall be long lines, and all other graduations shall
Greater than 39.0 to 41.0 0.2 Greater than 102.0 to 106.0 0.3
Greater than 41.0 0.3 Greater than 106.0 0.4
beshortlines(see5.4.6).Appropriatenumeralsshallbeplaced
at every full-degree graduation. If an arrow or other mark
Testing shall be in accordance with 6.3. Readings shall be
designating normal is used, the numeral at 37°C may be
rounded to one decimal place as provided in Recommended
eliminated.
Practice E29.
5.4.5 Fahrenheit Graduations—Fahrenheit thermometers
5.4.12 Ease of Resetting—The length of the residual mer-
shall be graduated in 0.2°F intervals. All full-degree gradua- curycolumnshallnotexceed20.6mm( ⁄16in.),andthetopof
tions shall be long lines, and the graduation for 98.6°F may
the column shall fall below 35.5°C (96°F) when tested in
alsobealonglineorothersuitablemark.Allothergraduations accordance with 6.4 (See description of hard shaker thermom-
shall be short lines (see 5.4.6). Appropriate numerals shall be eter in 3.2.9.)
placed at every even-degree graduation. 5.4.13 Temperature Retention—Each thermometer shall in-
dicate 41.0 6 0.2°C (106.0 6 0.3°F) when tested in accor-
5.4.6 Temperature Scale Graduation Marks—All short (0.1
dancewith6.5.Ifapplicable,asprovidedin6.3,theacceptable
and 0.2°) graduation lines shall not be less than 1.3 mm (0.05
indication shall be 40.8 6 0.2°C (105.6 6 0.3°F). (See
in.) in length, and all long graduation lines shall be at least
description of retreating index thermometer in 3.2.16.)
25% longer than the short lines. The graduation lines shall be
5.4.14 Workmanship—There shall be no constructional de-
substantially straight, uniformly spaced, of uniform width, and
fects that would prevent the observations of temperature. The
shallbeperpendiculartotheaxisofthestem.Theyshallnotbe
presence of unhealed fire cracks or fractures, when tested in
wider than the spaces between the graduations, nor wider than
0.46 mm (0.018 in.) and shall not be narrower than 0.10 mm accordance with 6.6, shall be considered evidence of discred-
itable workmanship.
(0.004 in.).
5.5 Fabrication of Ovulation-Scale Thermometers—
5.4.7 Normal Human Temperature Marks—The lines at
Thermometers designed for use in determining the date of
37°C (98.6°F) may be designated by an arrow or other
ovulation or the basal body temperature shall meet the preced-
suitable mark. If used, the mark shall be accurately positioned
1 ing requirements with the following exceptions:
to within a tolerance of 6 ⁄2 of the minimum graduated
5.5.1 Scale Range and Position—There shall not be more
interval.
than 3°C (4°F) per 38 mm (1 ⁄2 in.) of temperature scale.The
5.4.8 Legibility of Marks, Numbers, and Graduations—All
range of the scale shall be at least from 35.5 to 38°C (96 to
temperature scale graduations and numerals and all identifica-
100°F) as applicable. The 38°C (100°F) graduation mark
tionmarksshallbemadereadilylegiblebytheuseofcolorant.
shall be at least 3 mm ( ⁄8 in.) from the end of the bore.
Thecumulativeabsenceofcolorantfromgraduationlinesshall
5.5.2 Temperature Scale Graduations—Thermometers shall
notbemorethantheequivalentofonelonggraduationline,the
be graduated in intervals no greater than 0.05°C (0.1°F). All
cumulative absence of colorant from numbers shall not be
full-degreeandhalf-degreegraduationsshallbelonglines,and
more than the equivalent of one entire number, and the
all other graduations shall be short lines. The 0.05° and 0.1°
cumulative absence of colorant from letters shall not be more
graduationlinesshallbeclearlydifferentiablefromoneanother
than the equivalent of one complete letter.
(see 5.4.6). Numerals shall identify each full-degree mark on
5.4.9 Permanency of Marks, Numbers, and Graduations—
the scale.
When tested in accordance with 6.2, all temperature scale
5.5.3 Accuracy—No individual reading on any ovulation
graduations and numerals and all identification marks shall not
scale thermometer shall be in error by more than 6 0.1°C
fade or discolor in such a manner as to impair their legibility.
(0.2°F) at any point in the range 36.0°C (97.0°F) to 37.5°C
Th
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