ASTM E825-98

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E 825 – 98
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Specification for
Phase Change-Type Disposable Fever Thermometer for
1
Intermittent Determination of Human Temperature
This standard is issued under the fixed designation E 825; 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 which a specific requirement of marking and labeling is
logically applicable. It shall not be less than the smallest unit
1.1 This specification covers phase change-type clinical
intended for sale by the manufacturer or distributor to the final
thermometers that are designed and intended for one time use.
user.
2. Referenced Documents 3.2.7 temperature offset, n—designed difference in predic-
tive thermometer readings and water bath test temperatures.
2.1 ASTM Standards:
E 344 Terminology Relating to Thermometry and Hydrom-
4. Classification
2
etry
4.1 Phase change disposable thermometers for the intermit-
2.2 Other Standards:
tent determination of human temperature.
National Formulary, Volume XIII Code of Federal Regula-
tions, Title 21, Section 191, II 1971.
NOTE 1—The requirements of this specification shall not preclude the
manufacture and sale of special thermometers having different tempera-
3. Terminology
ture ranges and degrees of subdivision designed for specific medical uses.
Packaging on any “special” thermometers shall state that the thermometer
3.1 Definitions—The definitions given in Terminology
is a special one intended for a specific use and, therefore, is not necessarily
E 344 apply.
in compliance with this specification. In addition, the special thermometer
3.2 Definitions of Terms Specific to This Standard:
must be marked in such a way as to identify it as “special.”
3.2.1 intermittent determination of human temperature,
4.2 Scales, Celsius and Fahrenheit.
n—determination of human body temperature that is made
periodically by a series of entirely separate measurements.
NOTE 2—The Fahrenheit temperatures given in parentheses throughout
3.2.2 manufacturing lot, n—in the case of a continuous
this specification are not necessarily exact Celsius conversions but are the
values to be used when testing thermometers with Fahrenheit scales for
manufacturing process, a lot is a specific identified quantity or
conformance with this specification.
amount produced in a unit of time made in a manner that
assures its having uniform character and quality within speci-
5. Requirements
fied limits. In the case of a batch process, a lot means a batch
5.1 General—All thermometers represented as complying
or specific identified portion of a batch having uniform
with this specification shall meet all of the requirements
character and quality within specified limits.
specified herein. Terms are defined in Section 4.
3.2.3 measurement time, n—length of time required from
5.2 Temperature Range—The instrument shall cover the
the time of patient contact to the time when the thermometer
minimum range from 35 to 40.4 °C (96 to 104.8 °F) unless
may be removed to read within its stated accuracy.
otherwise obviously labeled. If any thermometer does not meet
3.2.4 predictive thermometer, n—any thermometer that pro-
the range 35 to 40.4 °C (96 to 104.8 °F), it shall additionally be
vides an indication of the final stabilized temperature of the
obviously marked as “Limited Range” on suitable packaging
measurement site in advance of the time for the sensing part of
units.
the thermometer to reach the equilibrium temperature of that
5.3 Accuracy—The accuracy of the thermometer shall be in
site.
conformance with Table 1 and Table 2 when tested in accor-
3.2.5 storage package, n—smallest package intended by the
dance with 6.2 at any point on the temperature scale of the
manufacturer for long-term storage at the user’s facility.
thermometer.
3.2.6 suitable packaging unit, n—unit(s) of packaging to
5.4 Measurement Retention—A measurement meeting the
accuracy requirements of 5.3 will be maintained for a mini-
1
This specification is under the jurisdiction of ASTM Committee E-20 on
mum of 1 min when tested in accordance with 6.2.4.
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
5.5 Operating Environment—When used in an environment
on Medical Thermometry.
Current edition approved April 10, 1998. Published March 1999. Originally in which the temperature is in the range from 18 to 33 °C (64
published as E 825 – 81. Discontinued February 1996 and reinstated as E 825 – 97.
to 92 °F), the thermometers,
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