ASTM E825-98(2009)
(Specification)Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
ABSTRACT
This specification covers the test methods and corresponding requirements for phase change-type disposable (for one time use only) clinical thermometers used for the intermittent determination of human temperature. When examined using the test methods suggested herein, sampled specimens shall comply with the specified requirements as to temperature range and graduation, accuracy, measurement retention, operating environment, storage environment, toxicity, workmanship, stability, and marking and labeling.
SCOPE
1.1 This specification covers phase change-type clinical thermometers that are designed and intended for one time use.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:E825 −98(Reapproved 2009)
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope measurementsiteinadvanceofthetimeforthesensingpartof
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—smallest package intended by the
2. Referenced Documents
manufacturer for long-term storage at the user’s facility.
2.1 ASTM Standards: 3.2.6 suitable packaging unit, n—unit(s) of packaging to
E344Terminology Relating to Thermometry and Hydrom- which a specific requirement of marking and labeling is
etry logically applicable. It shall not be less than the smallest unit
2.2 Other Standards: intended for sale by the manufacturer or distributor to the final
National Formulary, Volume XIII Code of Federal user.
Regulations, Title 21, Section191, II 1971.
3.2.7 temperature offset, n—designed difference in predic-
tive thermometer readings and water bath test temperatures.
3. Terminology
4. Classification
3.1 Definitions—ThedefinitionsgiveninTerminologyE344
4.1 Phase change disposable thermometers for the intermit-
apply.
tent determination of human temperature.
3.2 Definitions of Terms Specific to This Standard:
NOTE 1—The requirements of this specification shall not preclude the
3.2.1 intermittent determination of human temperature,
manufacture and sale of special thermometers having different tempera-
n—determination of human body temperature that is made
ture ranges and degrees of subdivision designed for specific medical uses.
periodically by a series of entirely separate measurements.
Packagingonany“special”thermometersshallstatethatthethermometer
isaspecialoneintendedforaspecificuseand,therefore,isnotnecessarily
3.2.2 manufacturing lot, n—in the case of a continuous
incompliancewiththisspecification.Inaddition,thespecialthermometer
manufacturing process, a lot is a specific identified quantity or
must be marked in such a way as to identify it as “special.”
amount produced in a unit of time made in a manner that
4.2 Scales, Celsius and Fahrenheit.
assures its having uniform character and quality within speci-
fied limits. In the case of a batch process, a lot means a batch
NOTE 2—The Fahrenheit temperatures given in parentheses throughout
this specification are not necessarily exact Celsius conversions but are the
or specific identified portion of a batch having uniform
values to be used when testing thermometers with Fahrenheit scales for
character and quality within specified limits.
conformance with this specification.
3.2.3 measurement time, n—length of time required from
5. Requirements
the time of patient contact to the time when the thermometer
may be removed to read within its stated accuracy. 5.1 General—All thermometers represented as complying
with this specification shall meet all of the requirements
3.2.4 predictive thermometer, n—any thermometer that pro-
specified herein. Terms are defined in Section 4.
vides an indication of the final stabilized temperature of the
5.2 Temperature Range—The instrument shall cover the
minimum range from 35 to 40.4 °C (96 to 104.8 °F) unless
This specification is under the jurisdiction of ASTM Committee F04 on
otherwiseobviouslylabeled.Ifanythermometerdoesnotmeet
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.33 on Medical/Surgical Instruments. therange35to40.4°C(96to104.8°F),itshalladditionallybe
Current edition approved May 1, 2009. Published June 2009. Originally
obviously marked as “Limited Range” on suitable packaging
approved in 1981. Discontinued February 1996 and reinstated as E825–97. Last
units.
previous edition approved in 2003 as E825–98 (2003). DOI: 10.1520/E0825-
98R09.
5.3 Accuracy—The accuracy of the thermometer shall be in
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
conformance with Table 1 and Table 2 when tested in accor-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
dance with 6.2 at any point on the temperature scale of the
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. thermometer.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E825−98 (2009)
TABLE 1 Accuracy of Thermometers With a Celsius Scale
labeling shall also bear a statement that the thermometers are
Temperature Range, °C Maximum Error, °C intended for single use only.
Below 35.8 ±0.3 5.10.2 Operating Instructions—Operating instructions must
35.8 to 36.9 ±0.2
be provided. When space limitations dictate, the operating
37.0 to 39.0 ±0.1
instructions on an individual thermometer may be omitted if
39.1 to 41.0 ±0.2
Above 41.0 ±0.3 detailed instructions are provided on or with a suitable pack-
aging unit.
5.10.3 Additional Marking and Labeling— Additional
TABLE 2 Accuracy of Thermometers With a Fahrenheit Scale
markingandlabelingthatmayberequiredby5.2,5.5,5.8,5.9,
Temperature Range, °F Maximum Error, °F
and 6.2.3 shall be clear, concise, and adequate for the intended
Below 98 ±0.4
purpose.Thetemperaturemeasurementoffsetshallbeincluded
98 to 102 ±0.2
in the labeling of the thermometers.
Above 102 ±0.4
5.11 Toxicity—When the thermometer is used as specified
by the manufacturer, its parts intended for contact with
anatomical sites during patient use and its melting point
5.4 Measurement Retention—A measurement meeting the
chemicals shall be nontoxic as determined by 6.5.
accuracy requirements of 5.3 will be maintained for a mini-
mum of 1 min when tested in accordance with 6.2.4.
6. Test Methods for Performance Verification
5.5 Operating Environment—When used in an environment
6.1 Significance and Use—This section describes the
in which the temperature is in the range from 18 to 33 °C (64
principles, apparatus, and procedures to be used to determine
to 92 °F), the thermometers, when tested in accordance with
the conformance of disposable thermometers to the require-
6.3, shall meet the requirements of 5.3. Any thermometer
ments of this specification. Each manufacturer or distributor
product not meeting this requirement shall be marked on a
whorepresentshisproductsasconformingtothisspecification
suitable packaging unit or other labeling of the thermometers
mayusestatisticallybasedsamplingplansthatareappropriate.
withacautioningstatementindicatingtheambienttemperature
He shall keep such essential records as are necessary to
range in which it can be used with specified accuracy.
document his claim that all the requirements of this specifica-
tion are met. This section does not include any procedure for
5.6 Graduation—The thermometer shall be graduated in
requirements that can be verified by visual inspection (such as
intervals no greater than 0.1 °C (0.2 °F). As a minimum,
5.2).
appropriate numerals shall be placed at every degree gradua-
tion for Celsius scale thermometers and at every even degree
6.2 Accuracy Test:
graduation for Fahrenheit scale thermometers.
6.2.1 Test Equipment Required—The test equipment shall
include constant-temperature water baths, the temperatures of
5.7 Workmanship—There shall be no constructional defects
which are uniform and are known to be within 60.03 °C
that would prevent the measurement of temperature within the
(60.05 °F), as measured by a thermometer or thermometry
accuracy requirements of 5.3.
systemforwhichthetemperaturecalibrationistraceabletothe
5.8 Stability—Thermometers shall meet all requirements of
International Temperature Scale of 1990 (ITS-90) as main-
this specification over their shelf life. If the shelf life of the
tained by the National Institute of Standards and Technology
productislessthan5yearswhenstoredincompliancewiththe
(NIST) or other appropriate National Standards Laboratory.
manufacturer’s instructions, an uncoded expiration date shall
The volume of each bath shall be a minimum of 1 L.
be displayed on the labeling of the product.
6.2.2 Procedure—Insert t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.