ASTM E1299-96(2023)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1299 − 96 (Reapproved 2023)
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. A number 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 Definitions of Terms Specific to This Standard:
3.2.1 phase-change-type fever thermometer, n—a reusable
1.1 This specification covers reusable phase-change-type
instrument utilizing the change of state of chemical composi-
clinical thermometers.
tions to measure and indicate an anatomical site temperature.
1.2 The following safety hazards caveat pertains only to the
3.2.2 retention time, n—the duration of time that the optimal
test method portion, Section 6, of this specification. This
signal for reading persists.
standard does not purport to address all of the safety concerns,
if any, associated with its use. It is the responsibility of the user
4. Classification
of this standard to establish appropriate safety, health, and
4.1 Phase-change-type reusable thermometers for determi-
environmental practices and determine the applicability of
nation of human temperature.
regulatory limitations prior to use.
4.2 Scales, Celsius and Fahrenheit.
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
5. Requirements
ization established in the Decision on Principles for the
5.1 General—All thermometers complying with this speci-
Development of International Standards, Guides and Recom-
fication shall meet all the requirements specified herein.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
5.2 Temperature Range—The instrument shall cover the
minimum range from 35.5 to 40.4 °C (96.0 to 104.8 °F).
2. Referenced Documents
5.3 Accuracy—Within the range specified, no individual
2.1 ASTM Standards:
reading shall be in error by more than the maximum errors
E344 Terminology Relating to Thermometry and Hydrom-
listed in Table 1 when tested in accordance with 6.2 at any
etry
point on the temperature scale of the thermometer.
F895 Test Method for Agar Diffusion Cell Culture Screening
5.4 Measurement Retention—A measurement meeting the
for Cytotoxicity
accuracy requirement of 5.3 will be maintained for a minimum
2.2 Code of Federal Regulations:
of 20 s when tested in accordance with 6.2.4.
CFR, Title 21, Section 191, II, 1971
5.5 Operating Environment—When used in an environment
3. Terminology
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
intervals no greater than 0.1 °C (0.2 °F). As a minimum,
appropriate numerals shall be placed at every half degree
This specification is under the jurisdiction of ASTM Committee F04 on
graduation for Celsius scale thermometers and every degree
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.33 on Medical/Surgical Instruments.
graduation for Fahrenheit scale thermometers.
Current edition approved Feb. 1, 2023. Published February 2023. Originally
5.7 Stability—Thermometers shall meet all requirements of
approved in 1989. Last previous edition approved in 2016 as E1299 – 96 (2016).
DOI: 10.1520/E1299-96R23.
this specification over their minimum shelf life of three years.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.8 Storage Environment—When tested in accordance with
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
6.4, thermometers shall meet the requirements of 5.3 after
the ASTM website.
having been stored in an environment of −20 to 50 °C (+4 °F
Available from U.S. Government Printing Office Superintendent of Documents,
to 120 °F), and a relative humidity of 15 to 85 %
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov. noncondensing, for a period of 30 days, providing that they
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1299 − 96 (2023)
TABLE 1 Maximum Error of Temperature Readings
6.2.2 Procedure—Insert the thermometers in the water bath
Celsius Scale and test in accordance with the procedures specified by the
Temperature Range, °C Maximum Error, °C
manufacturer. Use at least 20 temperature points distributed
Below 35.8 ±0.3
throughout the range on the scale of the thermometer for
35.8 to 36.9 ±0.2
37.0 to 39.0 ±0.1 obtaining data.
39.1 to 40.4 ±0.2
6.2.3 Sampling—For each manufacturing lot, use a mini-
mum of 200 thermometers in the accuracy determination,
Fahrenheit Scale
Temperature Range, °F Maximum Error, °F
making at least five measurements with each thermometer. The
Below 98.0 ±0.4
criteria for lot acceptance shall be published by the manufac-
98.0 to 102.0 ±0.2
turer.
Above 102.0 ±0.4
6.2.4 Measurement of Retention Time—After removing
thermometers from the water bath, wait 20 s and compare the
readings with those obtained immediately upon removing the
have been returned to an environment with a temperature of
thermometers from the water bath. These thermometers shall
between 18 to 33 °C (64 to 92 °F) and a relative humidity of
meet the requirements of 5.3 at the temperature extremes of 18
30 to 70 % for at least 24 h before testing.
and 33 °C (64 and 92 °F) and the relative humidity extremes of
5.9 Marking and Labeling:
15 and 85 %.
5.9.1 Identification—Suitable packaging units of the ther-
6.3 Operating Environment Test—This test is used to deter-
mometer shall bear in legible characters the name or
mine the compliance of the thermometers to the requirement of
trademark, or both, of the manufacturer or distributor and a
5.5.
designation (either a serial number or a code) to indicate the
6.3.1 Test Equipment:
specific manufacturing lot.
6.3.1.1 Constant-Temperature Water Baths (6.2.1).
5.9.2 Operating Instructions—Operating instructions shall
6.3.1.2 Forced-Circulation Air Oven, capable of heating
be provided with the packaging unit.
samples to 32 6 1 °C (90 6 2 °F).
5.9.3 Care and Cleaning Instructions—Instructions for the
6.3.1.3 Refrigerated Chamber, capable of cooling samples
care and cleaning of the thermometer shall be provided with
to 19 6 1 °C (66 6 2 °F).
the packaging unit. A procedure for decontaminating the
thermometer following each use shall be included with these
NOTE 1—The oven and refrigerator must be located in close proximity
instructions.
to the constant temperature water baths.
5.10 Toxicity—When the thermometer is used as specified
6.3.2 Procedure—Equilibrate sa
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