ASTM E825-98(2003)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E 825 – 98 (Reapproved 2003)
Standard Specification for
Phase Change-Type Disposable Fever Thermometer for
Intermittent Determination of Human Temperature
This standard is issued under the fixed designation E825; 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 (e) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope measurement site in advance of the time for the sensing part of
the thermometer to reach the equilibrium temperature of that
1.1 This specification covers phase change-type clinical
site.
thermometers that are designed and intended for one time use.
3.2.5 storage package, n—smallestpackageintendedbythe
2. Referenced Documents
manufacturer for long-term storage at the user’s facility.
3.2.6 suitable packaging unit, n—unit(s) of packaging to
2.1 ASTM Standards:
which a specific requirement of marking and labeling is
E344 Terminology Relating to Thermometry and Hydrom-
logically applicable. It shall not be less than the smallest unit
etry
intended for sale by the manufacturer or distributor to the final
2.2 Other Standards:
user.
National Formulary, Volume XIII Code of Federal Regula-
3.2.7 temperature offset, n—designed difference in predic-
tions, Title 21, Section 191, II 1971.
tive thermometer readings and water bath test temperatures.
3. Terminology
4. Classification
3.1 Definitions—The definitions given in Terminology
4.1 Phase change disposable thermometers for the intermit-
E344 apply.
tent determination of human temperature.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 intermittent determination of human temperature,
NOTE 1—The requirements of this specification shall not preclude the
n—determination of human body temperature that is made
manufacture and sale of special thermometers having different tempera-
periodically by a series of entirely separate measurements. ture ranges and degrees of subdivision designed for specific medical uses.
Packaging on any “special” thermometers shall state that the thermometer
3.2.2 manufacturing lot, n—in the case of a continuous
isaspecialoneintendedforaspecificuseand,therefore,isnotnecessarily
manufacturing process, a lot is a specific identified quantity or
incompliancewiththisspecification.Inaddition,thespecialthermometer
amount produced in a unit of time made in a manner that
must be marked in such a way as to identify it as “special.”
assures its having uniform character and quality within speci-
4.2 Scales, Celsius and Fahrenheit.
fied limits. In the case of a batch process, a lot means a batch
or specific identified portion of a batch having uniform
NOTE 2—The Fahrenheit temperatures given in parentheses throughout
character and quality within specified limits. this specification are not necessarily exact Celsius conversions but are the
values to be used when testing thermometers with Fahrenheit scales for
3.2.3 measurement time, n—length of time required from
conformance with this specification.
the time of patient contact to the time when the thermometer
may be removed to read within its stated accuracy.
5. Requirements
3.2.4 predictive thermometer, n—anythermometerthatpro-
5.1 General—All thermometers represented as complying
vides an indication of the final stabilized temperature of the
with this specification shall meet all of the requirements
specified herein. Terms are defined in Section 4.
This specification is under the jurisdiction of ASTM Committee E20 on
5.2 Temperature Range—The instrument shall cover the
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
minimum range from 35 to 40.4 °C (96 to 104.8 °F) unless
on Medical Thermometry.
otherwiseobviouslylabeled.Ifanythermometerdoesnotmeet
Current edition approved May 10, 2003. Published July 2003. Originally
approved in 1981. Discontinued February 1996 and reinstated as E825–97. Last
previous edition approved in 1998 as E825–98.
Annual Book of ASTM Standards, Vol 14.03.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E 825 – 98 (2003)
TABLE 2 Accuracy of Thermometers With a Fahrenheit Scale
therange35to40.4°C(96to104.8°F),itshalladditionallybe
obviously marked as “Limited Range” on suitable packaging Temperature Range, °F Maximum Error, °F
units.
Below 98 60.4
98 to 102 60.2
5.3 Accuracy—The accuracy of the thermometer shall be in
Above 102 60.4
conformance with Table 1 and Table 2 when tested in accor-
dance with 6.2 at any point on the temperature scale of the
thermometer.
5.4 Measurement Retention—A measurement meeting the
5.10.2 Operating Instructions—Operatinginstructionsmust
accuracy requirements of 5.3 will be maintained for a mini-
be provided. When space limitations dictate, the operating
mum of 1 min when tested in accordance with 6.2.4.
instructions on an individual thermometer may be omitted if
5.5 Operating Environment—Whenusedinanenvironment
detailed instructions are provided on or with a suitable pack-
in which the temperature is in the range from 18 to 33 °C (64
aging unit.
to 92 °F), the thermometers, when tested in accordance with
5.10.3 Additional Marking and Labeling— Additional
6.3, shall meet the requirements of 5.3. Any thermometer
markingandlabelingthatmayberequiredby5.2,5.5,5.8,5.9,
product not meeting this requirement shall be marked on a
and 6.2.3 shall be clear, concise, and adequate for the intended
suitable packaging unit or other labeling of the thermometers
purpose.Thetemperaturemeasurementoffsetshallbeincluded
withacautioningstatementindicatingtheambienttemperature
in the labeling of the thermometers.
range in which it can be used with specified accuracy.
5.11 Toxicity—When the thermometer is used as specified
5.6 Graduation—The thermometer shall be graduated in
by the manufacturer, its parts intended for contact with
intervals no greater than 0.1 °C (0.2 °F). As a minimum,
anatomical sites during patient use and its melting point
appropriate numerals shall be placed at every degree gradua-
chemicals shall be nontoxic as determined by 6.5.
tion for Celsius scale thermometers and at every even degree
graduation for Fahrenheit scale thermometers.
6. Test Methods for Performance Verification
5.7 Workmanship—There shall be no constructional defects
that would prevent the measurement of temperature within the
6.1 Significance and Use—This section describes the prin-
accuracy requirements of 5.3.
ciples, apparatus, and procedures to be used to determine the
5.8 Stability—Thermometers shall meet all requirements of
conformance of disposable thermometers to the requirements
this specification over their shelf life. If the shelf life of the
of this specification. Each manufacturer or distributor who
productislessthan5yearswhenstoredincompliancewiththe
representshisproductsasconformingtothisspecificationmay
manufacturer’s instructions, an uncoded expiration date shall
use statistically based sampling plans that are appropriate. He
be displayed on the labeling of the product.
shall keep such essential records as are necessary to document
5.9 Storage Environment—When tested in accordance with
his claim that all the requirements of this specification are met.
6.4,thermometersshallmeettherequirementsof5.3afterthey
This section does not include any procedure for requirements
have been stored for 1 day at any point in an environment of
that can be verified by visual inspection (such as 5.2).
−18 to 38 °C (0 to 100 °F) and at relative humidities from 15
6.2 Accuracy Test:
to 90%. When tested in accordance with 6.4, thermometers
6.2.1 Test Equipment Required—The test equipment shall
shall also meet the requirements of 5.3 after they have been
include constant-temperature water baths, the temperatures of
storedfor1monthatanypointinanenvironmentof15.5to32
which are uniform and are known to be within 60.03 °C
°C (60 to 90 °F) and 30 to 75% relative humidity. Any
(60.05 °F), as measured by a thermometer or thermometry
thermometer product not meeting this requirement shall be
systemforwhichthetemperaturecalibrationistraceabletothe
marked on a suitable packaging unit or other
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