ASTM E667-98(2009)
(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.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E667 −98 (Reapproved 2009)
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.
1. Scope E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers mercury-in-glass, reusable
E344Terminology 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,
dimensions, temperature scale ranges, and graduations, as well
3.1 Definitions—ThedefinitionsgiveninTerminologyE344
as for thermometer stability, ease of resetting, retention of
apply to this specification.
temperature indication, and for accuracy of scale reading.
3.2 Definitions of Terms Specific to This Standard:
Appropriate methods of testing to determine compliance are
3.2.1 bore, n—hole or lumen in the stem.
provided. Also included is a glossary of terms used in the
3.2.2 calibration date, n—date on which the scale is affixed
standard and an appendix with additional information on
to a thermometer.
thermometer glasses and stability.
3.2.3 ceramic marking, n—marking produced by fusing a
1.2 All values of temperature in this standard are with
ceramic colorant onto the glass surface.
reference to the International Temperature Scale of 1990.
3.2.4 constriction, n—obstruction in the bore of a clinical
1.3 This specification was developed to provide nationally
thermometer which permits the passage of mercury from the
recognized marketing classifications and quality requirements
bulb when the bulb is heated, but which restricts its passage
for mercury-in-glass, maximum self-registering clinical ther-
back to the bulb when heat is removed.
mometers.Itisalsointendedtoprovideproducers,distributors,
and users with a common understanding of the characteristics
3.2.5 fire cracks, n—cracks in glass caused by local tem-
of this product.
perature shock.
1.4 The following precautionary statement pertains only to
3.2.6 flat magnifying lens, n—thermometer stem glass in
the test method portion, Section 6 of this specification: This
which the numerals, graduations, and lens lie on the same
standard does not purport to address all of the safety concerns,
relative surface.
if any, associated with its use. It is the responsibility of the user
3.2.6.1 Discussion—Itissonamedforitsapproximatelyflat
of this standard to establish appropriate safety and health
cross section (See Fig. 1.)
practices and determine the applicability of regulatory limita-
3.2.7 fractures, n—internal or external breaks or cracks in
tions prior to use.
the glass.
3.2.7.1 Discussion—Internal fractures usually occur in the
2. Referenced Documents
area between the bulb and the constriction.
2.1 ASTM Standards:
3.2.8 graduations, n—series of lines on the stem of the
thermometer that designate the temperature scale intervals.
3.2.9 hard shaker thermometer, n—thermometer in which
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of the constriction is overly severe thereby restricting the passage
F04.33 on Medical/Surgical Instruments.
ofmercurybacktothebulbcausingthethermometertofailthe
Current edition approved Oct. 15, 2009. Published December 2009. Originally
ease-of-resetting requirements.
approvedin1979.Lastpreviouseditionapprovedin2003asE667–98(2003).DOI:
10.1520/E0667-98R09.
3.2.10 index, n—upper point of the mercury column whose
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
position, when noted with respect to the corresponding numer-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
als and graduations, indicates the temperature of the mercury
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. within the bulb.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E667−98 (2009)
Cross section of magnifying lens stems.
FIG. 1Composite and Sectional Views of Clinical Thermometers (These sketches are for illustration only.)
3.2.11 magnifying lens, n—stem glass that, due to its 3.2.19 subnormal thermometer, n—clinical thermometer
configuration, results in a magnification of the mercury col- specifically designed for obtaining lower than normal body
umn. temperatures.
3.2.19.1 Discussion—A subnormal thermometer is marked
3.2.12 normal human temperature, n—conventionally ac-
with a subnormal scale range. See 4.4.
cepted average body temperature in healthy human beings
(37°C or 98.6°F). 3.2.20 triangular magnifying lens, n—thermometer stem
glassinwhichthenumeralsandgraduationslieonsurfacesthat
3.2.13 ovulation thermometer, n—thermometer specifically
smoothly merge to form a lens.
designed for obtaining body temperature for the purpose of
3.2.20.1 Discussion—It is so named for its approximately
determining the date of ovulation or the basal body tempera-
triangular cross section. (See Fig. 1.)
ture.
3.2.14 reflecting stem, n—stem glass containing a colored
4. Classification
stripe along its length in a location that, when reflected on the
4.1 Clinical thermometers covered by these specifications
mercury column, allows greater contrast and enables the
are generally available in the following classifications. Other
column to appear tinted.
designs and configurations of thermometers meeting the re-
3.2.15 residual mercury column, n—mercury that lies in the
quirements specified herein shall also be considered as com-
bore of the stem above the constriction.
plying with this specification.
3.2.16 retreating index thermometer, n—thermometer in
NOTE 1—The requirements of this specification shall not preclude the
which the constriction is not sufficiently small to prevent the
manufacture and sale of special thermometers having different tempera-
passage of mercury back to the bulb (or the mercury index
ture ranges and degrees of subdivision designed for specific medical uses.
Packagingonany“special”thermometersshallstatethatthethermometer
from falling) without shaking when heat is removed from the
isaspecialoneintendedforaspecificuseand,therefore,isnotnecessarily
bulb.
incompliancewiththisspecification.Inaddition,thespecialthermometer
3.2.17 scale range, n—range of temperature through which
must be marked in such a way so as to identify it as “special.”
a thermometer is usable.
4.2 Types—Thermometers are classified by types as follows
(see Fig. 2):
3.2.18 stained marking, n—marking produced by diffusing
colorant into the glass surface. 4.2.1 Human:
E667−98 (2009)
FIG. 2Types of Clinical Thermometers (These sketches are for illustration only.)
conformance with this specification.
4.2.1.1 Basal or Ovulation, with large cylindrical bulb
(ovulation scale).
4.5 Marking—Thermometer markings are classified as fol-
4.2.1.2 Multiuse (Oral or Rectal), with stubby bulb (regular
lows:
scale).
4.5.1 Etched and filled.
4.2.1.3 Oral, with cylindrical bulb (regular scale).
4.5.2 Stained.
4.2.1.4 Rectal, with pear shaped bulb (regular scale).
4.5.3 Ceramic marked.
4.2.1.5 Subnormal
4.5.4 Markedinotherwaysthatmeetalloftherequirements
4.2.2 Veterinary:
of this specification.
4.2.2.1 Ring Top, 100-mm (4 in.), with stubby bulb (regular
scale).
5. Requirements
4.2.2.2 Heavy Duty Ring Top, 125-mm (5 in.) with stubby
bulb (extended scale).
5.1 General—All thermometers represented as complying
with this specification shall meet all of the requirements
4.3 Stems—Thermometer stems are classified as follows
specified herein. Terms shall be as defined in Section 4.
(see Fig. 2):
4.3.1 Flat magnifying lens.
5.2 Glass—Thermometers shall be made from bulb glass
4.3.2 Triangular reflecting magnifying lens.
andmagnifyinglensstemglass(glasses)havingpropertiesand
4.3.3 Triangular magnifying lens.
characteristics that ensure stability, accuracy, and reliability in
4.4 Scales—Thermometertemperaturescalesandrangesare accordance with the requirements of this specification. (See
Appendix X1.)
classified as follows:
4.4.1 Celsius (formerly known as Centigrade):
5.3 Mercury—Mercury used in the thermometers shall have
4.4.1.1 Regular Scale, at least 35.5 to 41°C,
the purity, properties, and characteristics that will enable the
4.4.1.2 Ovulation Scale, at least 35.5 to 38°C,
finished thermometers to comply with all the performance
4.4.1.3 Extended Scale, at least 35.5 to 44°C, and
requirements of this specification. In addition, when finished
4.4.1.4 Subnormal Scale, at least 21 to 38°C.
thermometers are visually examined, the bulb and the mercury
4.4.2 Fahrenheit (Note 2):
column shall be free of gas or other foreign material.
4.4.2.1 Regular Scale, at least 96 to 106°F,
5.4 Fabrication of Regular-Scale Thermometer for Human
4.4.2.2 Ovulation Scale, at least 96 to 100°F,
Use:
4.4.2.3 Extended Scale, at least 96 to 110°F,
5.4.1 Length—The overall length of the thermometers shall
4.4.2.4 Subnormal Scale, at least 70 to 100°F.
not be less than 98 mm (3 ⁄8 in.).
NOTE 2—The Fahrenheit temperatures given in parentheses throughout
5.4.2 Thickness of Stem—No dimension of the cross section
this specification are not necessarily exact Celsius conversions but are the
values to be used when testing thermometers with Fahrenheit scales for offlatmagnifyingstemsshallbegreaterthan7.6mm(0.30in.)
E667−98 (2009)
nor less than 3.6 mm (0.14 in.). No dimension of the cross 5.4.10 Stability—Thermometers shall be stabilized by natu-
sectionoftriangularstemsshallbelessthan3.6mm(0.14in.). ral or artificial means to assure that the requirements of this
specification will be maintained by the thermometers while in
5.4.3 Scale Range and Position—There shall not be more
normal use (see Appendix X1).
than 5.0°C (9.0°F) per 25.4 mm (1 in.) of temperature scale.
5.4.11 Accuracy—No individual reading on any non-special
The range of scale shall be at least from 35.5 to 41°C (96 to
scale thermometer shall be in error by more than the following
106°F). The 35.5°C (96°F) graduation mark shall not be less
in the ranges indicated:
than11mm( ⁄16in.)fromthebaseofthemercurycolumn.The
Celsius Scale, °C Fahrenheit Scale, °F
41°C (106°F) mark shall be at least 3 mm ( ⁄8 in.) from the
Maxi- Maxi-
end of the bore.
Range mum Range mum
Error Error
5.4.4 Celsius Graduations—Celsius thermometers shall be
graduated in 0.1°C intervals. All full-degree and half-degree
Less than 35.8 0.3 Less than 96.4 0.4
35.8 to less than 37.0 0.2 96.4 to less than 98.0 0.3
graduations shall be long lines, and all other graduations shall
37.0 to 39.0 0.1 98.0 to 102.0 0.2
beshortlines(see5.4.6).Appropriatenumeralsshallbeplaced
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
at every full-degree graduation. If an arrow or other mark
designating normal is used, the numeral at 37°C may be Testing shall be in accordance with 6.3. Readings shall be
eliminated. rounded to one decimal place as provided in Recommended
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-
5.4.6 Temperature Scale Graduation Marks—All short (0.1
dicate 41.0 6 0.2°C (106.0 6 0.3°F) when tested in accor-
and 0.2°) graduation lines shall not be less than 1.3 mm (0.05
dancewith6.5.Ifapplicable,asprovidedin6.3,theacceptable
in.) in length, and all long graduation lines shall be at least
indication shall be 40.8 6 0.2°C (105.6 6 0.3°F). (See
25% longer than the short lines. The graduation lines shall be
description of retreating index thermometer in 3.2.16.)
substantially straight, uniformly spaced, of uniform width, and
5.4.14 Workmanship—There shall be no constructional de-
shallbeperpendiculartotheaxisofthestem.Theyshallnotbe
fects that would prevent the observations of temperature. The
wider than the spaces between the graduations, nor wider than
presence of unhealed fire cracks or fractures, when tested in
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-
(0.004 in.). itable workmanship.
5.4.7 Normal Human Temperature Marks—The lines at
5.5 Fabrication of Ovulation-Scale Thermometers—
37°C (98.6°F) may be designated by an arrow or other
Thermometers designed for use in determining the date of
suitable mark. If used, the mark shall be accurately positioned ovulation or the basal body temperature shall meet the preced-
to within a tolerance of 6 ⁄2 of the minimum graduated ing requirements with the following exceptions:
interval. 5.5.1 Scale Range and Position—There shall not be more
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). Nu
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.