ASTM E1299-96

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: E 1299 – 96
Standard Specification for
Reusable Phase-Change-Type Fever Thermometer for
Intermittent Determination of Human Temperature
This standard is issued under the fixed designation E 1299; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 5. Requirements
1.1 This specification covers reusable phase-change-type 5.1 General—All thermometers complying with this speci-
clinical thermometers. fication shall meet all the requirements specified herein.
1.2 The following safety hazards caveat pertains only to the 5.2 Temperature Range—The instrument shall cover the
test method portion, Section 6, of this specification. This minimum range from 35.5 to 40.4°C (96.0 to 104.8°F).
standard does not purport to address all of the safety concerns, 5.3 Accuracy—Within the range specified, no individual
if any, associated with its use. It is the responsibility of the user reading shall be in error by more than the maximum errors
of this standard to establish appropriate safety and health listed in Table 1 when tested in accordance with 6.2 at any
practices and determine the applicability of regulatory limita- point on the temperature scale of the thermometer.
tions prior to use. 5.4 Measurement Retention—A measurement meeting the
accuracy requirement of 5.3 will be maintained for a minimum
2. Referenced Documents
of 20 s when tested in accordance with 6.2.4.
2.1 ASTM Standards: 5.5 Operating Environment—When used in an environment
E 344 Terminology Relating to Thermometry and Hydrom-
in which the temperature is in the range of 18 to 33°C (64 to
etry 92°F), the thermometers, when tested in accordance with 6.3,
F 895 Test Method for Agar Diffusion Cell Culture Screen-
shall meet the requirements of 5.3 and 5.4.
ing for Cytotoxicity 5.6 Graduation—The thermometer shall be graduated in
2.2 Code of Federal Regulations :
intervals no greater than 0.1°C (0.2°F). As a minimum,
CFR Title 21, Section 191, II, 1971 appropriate numerals shall be placed at every half degree
graduation for Celsius scale thermometers and every degree
3. Terminology
graduation for Fahrenheit scale thermometers.
3.1 Definitions:
5.7 Stability—Thermometers shall meet all requirements of
3.1.1 The definitions given in Terminology E 344 apply to
this specification over their minimum shelf life of three years.
this standard.
5.8 Storage Environment—When tested in accordance with
3.2 Definitions of Terms Specific to This Standard:
6.4, thermometers shall meet the requirements of 5.3 after
3.2.1 phase-change-type fever thermometer, n—a reusable
having been stored in an environment of − 20 to 50°C ( + 4°F
instrument utilizing the change of state of chemical composi-
to 120°F), and a relative humidity of 15 to 85 % noncondens-
tions to measure and indicate an anatomical site temperature.
ing, for a period of thirty days, providing that they have been
3.2.2 retention time, n—the duration of time that the optimal
returned to an environment with a temperature of between 18
signal for reading persists.
to 33°C (64 to 92°F) and a relative humidity of 30 to 70 % for
at least 24 h before testing.
4. Classification
5.9 Marking and Labeling:
4.1 Phase-change-type reusable thermometers for determi-
5.9.1 Identification—Suitable packaging units of the ther-
nation of human temperature.
mometer shall bear in legible characters the name or trade-
4.2 Scales, Celsius and Fahrenheit.
mark, or both, of the manufacturer or distributor and a
designation (either a serial number or a code) to indicate the
specific manufacturing lot.
This specification is under the jurisdiction of ASTM Committee E-20 on
5.9.2 Operating Instructions—Operating instructions shall
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
be provided with the packaging unit.
on Medical Thermometry.
5.9.3 Care and Cleaning Instructions—Instructions for the
Current edition approved May 10, 1996. Published June 1996. Originally
published as E 1299 – 89. Last previous edition E 1299 – 89.
care and cleaning of the thermometer shall be provided with
Annual Book of ASTM Standards, Vol 14.03.
the packaging unit. A procedure for decontaminating the
Annual Book of ASTM Standards, Vol 13.01.
thermometer following each use shall be included with these
Available from the Superintendent of Documents, US Government Printing
Office, Washington, DC 20402. instructions.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 1299
TABLE 1 Maximum Error of Temperature Readings
6.3.1 Test Equipment:
Celsius Scale 6.3.1.1 Constant-Temperature Water Baths, (6.2.1),
Temperature Range, °C Maximum Error, °C
6.3.1.2 Forced-Circulation Air Oven, capable of heating
Below 35.8 60.3
samples to 32 6 1°C (90 6 2°F),
35.8 to 36.9 60.2
37.0 to 39.0 60.1 6.3.1.3 Refrigerated Chamber, capable of cooling samples
39.1 to 40.4 60.2
to 19 6 1°C (66 6 2°F).
Fahrenheit Scale
NOTE 1—The oven and refrigerator must be located in close proximity
Temperature Range, °F Maximum Error, °F
to the constant temperature water baths.
Below 98.0 60.4
98.0 to 102.0 60.2
6.3.2 Procedure—Equilibrate samples of thermometers in
Above 102.0 60.4
an immediate ready-to-use status (free of all packaging) at the
two temperature extremes, 19 and 32°C (66 and 92°F), for at
least 1 h. Remove the thermometers from these operating
5.10 Toxicity—When the thermometer is used as specified
environments and insert them into the test water bath within 10
by the manufacturer, the parts intended for contact with intact
s of removal from either the 32°C oven or the 19° chamber and
natural channels or intact body surfaces during patient use and
complete the accuracy test in accordance with 6.2.2 and 6.2.4.
its phase change chemical compositions shall be nontoxic as
6.4 Storage Environment Test—This test is used to deter-
determined by 6.5.
mine the compliance of the thermometers to the requirements
6. Test Methods for Performance Verification
of 5.8.
6.1 General—This section describes the principles, appara-
6.4.1 Test Equipment:
tus, and procedures to be used to determine the conformance of
6.4.1.1 Constant-Temperature Water Baths, (6.2.1).
phase change reusable thermometers to the requirements of this
6.4.1.2 Environmental Test Chamber, capable of producing
standard. Each manufacturer or distributor when representing
environments of − 206 2°C (−4 6 4°F) at 15 and 85 %
products as conforming to this standard may use st
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