ASTM E1299-96(2010)
(Specification)Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature
Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature
ABSTRACT
This specification covers reusable phase-change-type clinical thermometers for determination of human temperature. The following test method shall be performed for performance verification: accuracy test; operating environment test; storage environment test; toxicity test (extract); toxicity test (chemical ingestion); and cleaning tests.
SCOPE
1.1 This specification covers reusable phase-change-type clinical thermometers.
1.2 The following safety hazards caveat pertains only to the test method portion, Section 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:E1299 −96(Reapproved 2010)
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Classification
1.1 This specification covers reusable phase-change-type 4.1 Phase-change-type reusable thermometers for determi-
clinical thermometers. nation of human temperature.
1.2 The following safety hazards caveat pertains only to the
4.2 Scales, Celsius and Fahrenheit.
test method portion, Section 6, of this specification. This
standard does not purport to address all of the safety concerns,
5. Requirements
if any, associated with its use. It is the responsibility of the user
5.1 General—All thermometers complying with this speci-
of this standard to establish appropriate safety and health
fication shall meet all the requirements specified herein.
practices and determine the applicability of regulatory limita-
5.2 Temperature Range—The instrument shall cover the
tions prior to use.
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
E344Terminology 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.
F895TestMethodforAgarDiffusionCellCultureScreening
5.4 Measurement Retention—A measurement meeting the
for Cytotoxicity
accuracyrequirementof5.3willbemaintainedforaminimum
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
92 °F), the thermometers, when tested in accordance with 6.3,
3.1 Definitions:
shall meet the requirements of 5.3 and 5.4.
3.1.1 The definitions given in Terminology E344 apply to
this standard.
5.6 Graduation—The thermometer shall be graduated in
3.2 Definitions of Terms Specific to This Standard: intervals no greater than 0.1 °C (0.2 °F). As a minimum,
3.2.1 phase-change-type fever thermometer, n—a reusable
appropriate numerals shall be placed at every half degree
instrument utilizing the change of state of chemical composi- graduation for Celsius scale thermometers and every degree
tions to measure and indicate an anatomical site temperature.
graduation for Fahrenheit scale thermometers.
3.2.2 retention time, n—thedurationoftimethattheoptimal
5.7 Stability—Thermometers shall meet all requirements of
signal for reading persists.
this specification over their minimum shelf life of three years.
5.8 Storage Environment—When tested in accordance with
This specification is under the jurisdiction of ASTM Committee F04 on
6.4, thermometers shall meet the requirements of 5.3 after
Medical and Surgical Materials and Devices and is the direct responsibility of
havingbeenstoredinanenvironmentof−20to50°C(+4°F
Subcommittee F04.33 on Medical/Surgical Instruments.
to 120 °F), and a relative humidity of 15 to 85 %
Current edition approved June 1, 2010. Published June 2010. Originally
noncondensing, for a period of thirty days, providing that they
approved in 1989. Last previous edition approved in 2002 as E1299–96 (2002).
DOI: 10.1520/E1299-96R10.
have been returned to an environment with a temperature of
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
between 18 to 33 °C (64 to 92 °F) and a relative humidity of
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
30 to 70% for at least 24 h before testing.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
5.9 Marking and Labeling:
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
5.9.1 Identification—Suitable packaging units of the ther-
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov. mometer shall bear in legible characters the name or
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1299−96 (2010)
TABLE 1 Maximum Error of Temperature Readings
6.2.3 Sampling—For each manufacturing lot, use a mini-
Celsius Scale mum of 200 thermometers in the accuracy determination,
Temperature Range, °C Maximum Error, °C
makingatleastfivemeasurementswitheachthermometer.The
Below 35.8 ±0.3
criteria for lot acceptance shall be published by the manufac-
35.8 to 36.9 ±0.2
37.0 to 39.0 ±0.1 turer.
39.1 to 40.4 ±0.2
6.2.4 Measurement of Retention Time—After removing
thermometers from the water bath, wait 20 s and compare the
Fahrenheit Scale
Temperature Range, °F Maximum Error, °F
readings with those obtained immediately upon removing the
Below 98.0 ±0.4
thermometers from the water bath. These thermometers shall
98.0 to 102.0 ±0.2
meettherequirementsof5.3atthetemperatureextremesof18
Above 102.0 ±0.4
and33°C(64and92°F)andtherelativehumidityextremesof
15 and 85%.
6.3 Operating Environment Test—This test is used to deter-
trademark, or both, of the manufacturer or distributor and a
minethecomplianceofthethermometerstotherequirementof
designation (either a serial number or a code) to indicate the
5.5.
specific manufacturing lot.
6.3.1 Test Equipment:
5.9.2 Operating Instructions—Operating instructions shall
6.3.1.1 Constant-Temperature Water Baths, (6.2.1),
be provided with the packaging unit.
6.3.1.2 Forced-Circulation Air Oven, capable of heating
5.9.3 Care and Cleaning Instructions—Instructions for the
samples to 32 61°C(90 6 2 °F),
care and cleaning of the thermometer shall be provided with
6.3.1.3 Refrigerated Chamber, capable of cooling samples
the packaging unit. A procedure for decontaminating the
to 19 61°C(66 6 2 °F).
thermometer following each use shall be included with these
instructions.
NOTE 1—The oven and refrigerator must be located in close proximity
to the constant temperature water baths.
5.10 Toxicity—When the thermometer is used as specified
6.3.2 Procedure—Equilibrate samples of thermometers in
by the manufacturer, the parts intended for contact with intact
an immediate ready-to-use status (free of all packaging) at the
natural channels or intact body surfaces during patient use and
two temperature extremes, 19 and 32 °C (66 and 92 °F), for at
its phase change chemical compositions shall be nontoxic as
least 1 h. Remove the thermometers from these operating
determined by 6.5.
environmentsandinsertthemintothetes
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