ASTM E1299-96(2002)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E1299 – 96 (Reapproved 2002)
Standard Specification for
Reusable Phase-Change-Type Fever Thermometer for
Intermittent Determination of Human Temperature
This standard is issued under the fixed designation E1299; 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 3.2.2 retention time, n—thedurationoftimethattheoptimal
signal for reading persists.
1.1 This specification covers reusable phase-change-type
clinical thermometers.
4. Classification
1.2 The following safety hazards caveat pertains only to the
4.1 Phase-change-type reusable thermometers for determi-
test method portion, Section 6, of this specification. This
nation of human temperature.
standard does not purport to address all of the safety concerns,
4.2 Scales, Celsius and Fahrenheit.
if any, associated with its use. It is the responsibility of the user
of this standard to establish appropriate safety and health
5. Requirements
practices and determine the applicability of regulatory limita-
5.1 General—All thermometers complying with this speci-
tions prior to use.
fication shall meet all the requirements specified herein.
5.2 Temperature Range—The instrument shall cover the
2. Referenced Documents
minimum range from 35.5 to 40.4°C (96.0 to 104.8°F).
2.1 ASTM Standards:
5.3 Accuracy—Within the range specified, no individual
E344 Terminology Relating to Thermometry and Hydrom-
reading shall be in error by more than the maximum errors
etry
listed in Table 1 when tested in accordance with 6.2 at any
F895 Test Method for Agar Diffusion Cell Culture Screen-
point on the temperature scale of the thermometer.
ing for Cytotoxicity
3 5.4 Measurement Retention—A measurement meeting the
2.2 Code of Federal Regulations :
accuracyrequirementof5.3willbemaintainedforaminimum
CFR Title 21, Section 191, II, 1971
of 20 s when tested in accordance with 6.2.4.
3. Terminology 5.5 Operating Environment—Whenusedinanenvironment
in which the temperature is in the range of 18 to 33°C (64 to
3.1 Definitions:
92°F), the thermometers, when tested in accordance with 6.3,
3.1.1 The definitions given in Terminology E344 apply to
shall meet the requirements of 5.3 and 5.4.
this standard.
5.6 Graduation—The thermometer shall be graduated in
3.2 Definitions of Terms Specific to This Standard:
intervals no greater than 0.1°C (0.2°F). As a minimum,
3.2.1 phase-change-type fever thermometer, n—a reusable
appropriate numerals shall be placed at every half degree
instrument utilizing the change of state of chemical composi-
graduation for Celsius scale thermometers and every degree
tions to measure and indicate an anatomical site temperature.
graduation for Fahrenheit scale thermometers.
5.7 Stability—Thermometers shall meet all requirements of
This specification is under the jurisdiction of ASTM Committee F04 on
this specification over their minimum shelf life of three years.
Medical and Surgical Materials and Devices and is the direct responsibility of
5.8 Storage Environment—When tested in accordance with
Subcommittee F04.33 on Medical/Surgical Instruments.
6.4, thermometers shall meet the requirements of 5.3 after
Current edition approved May 10, 2002. Published June 1996. Originally
published as E1299–89. Last previous edition E1299–96. DOI: 10.1520/E1299-
having been stored in an environment of−20 to 50°C (+4°F
96R02.
to 120°F), and a relative humidity of 15 to 85% noncondens-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ing, for a period of thirty days, providing that they have been
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
returned to an environment with a temperature of between 18
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
to 33°C (64 to 92°F) and a relative humidity of 30 to 70% for
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
at least 24 h before testing.
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
5.9 Marking and Labeling:
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E1299 – 96 (2002)
TABLE 1 Maximum Error of Temperature Readings
6.2.3 Sampling—For each manufacturing lot, use a mini-
Celsius Scale mum of 200 thermometers in the accuracy determination,
Temperature Range, °C Maximum Error, °C
makingatleastfivemeasurementswitheachthermometer.The
Below 35.8 60.3
criteria for lot acceptance shall be published by the manufac-
35.8 to 36.9 60.2
37.0 to 39.0 60.1 turer.
39.1 to 40.4 60.2
6.2.4 Measurement of Retention Time—After removing
thermometers from the water bath, wait 20 s and compare the
Fahrenheit Scale
Temperature Range, °F Maximum Error, °F
readings with those obtained immediately upon removing the
Below 98.0 60.4
thermometers from the water bath. These thermometers shall
98.0 to 102.0 60.2
meettherequirementsof5.3atthetemperatureextremesof18
Above 102.0 60.4
and 33°C (64 and 92°F) and the relative humidity extremes of
15 and 85%.
6.3 Operating Environment Test—This test is used to deter-
5.9.1 Identification—Suitable packaging units of the ther-
minethecomplianceofthethermometerstotherequirementof
mometer shall bear in legible characters the name or trade-
5.5.
mark, or both, of the manufacturer or distributor and a
6.3.1 Test Equipment:
designation (either a serial number or a code) to indicate the
6.3.1.1 Constant-Temperature Water Baths,(6.2.1),
specific manufacturing lot.
6.3.1.2 Forced-Circulation Air Oven, capable of heating
5.9.2 Operating Instructions—Operating instructions shall
samples to 32 6 1°C (90 6 2°F),
be provided with the packaging unit.
6.3.1.3 Refrigerated Chamber, capable of cooling samples
5.9.3 Care and Cleaning Instructions—Instructions for the
to 19 6 1°C (66 6 2°F).
care and cleaning of the thermometer shall be provided with
the packaging unit. A procedure for decontaminating the
NOTE 1—The oven and refrigerator must be located in close proximity
thermometer following each use shall be included with these
to the constant temperature water baths.
instructions.
6.3.2 Procedure—Equilibrate samples of thermometers in
5.10 Toxicity—When the thermometer is used as specified
an immediate ready-to-use status (free of all packaging) at the
by the manufacturer, the parts intended for contact with intact
two temperature extremes, 19 and 32°C (66 and 92°F), for at
natural channels or intact body surfaces during patient use and
least 1 h. Remove the thermometers from these operating
its phase change chemical compositions shall be nontoxic as
environmentsandinsertthemintothetestwaterbathwithin10
dete
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