ASTM E1112-00
(Specification)Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
SCOPE
1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures.
1.2 This specification does not cover infrared thermometers. Specification E1965 covers specifications of IR thermometers.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification. This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the users of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E 1112 – 00
Standard Specification for
Electronic Thermometer for Intermittent Determination of
Patient Temperature
This standard is issued under the fixed designation E1112; 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.
1. Scope 2.4 Federal Regulations:
CFR Part 87 Establishment Registration and Premarket
1.1 This specification covers electronic instruments in-
Notification Procedure
tended for intermittent monitoring of patient temperatures.
1.2 Thisspecificationdoesnotcoverinfraredthermometers.
3. Terminology
Specification E1965 covers specifications for IR thermom-
3.1 Definitions:
eters.
3.1.1 The definitions given in Terminology E344 shall
1.3 The values stated in SI units are to be regarded as the
apply to this standard.
standard.
3.2 Definitions of Terms Specific to This Standard:
1.4 The following precautionary caveat pertains only to the
3.2.1 battery charger, n—an electrical circuit designed to
test method portion, Section 5, of this specification. This
restore the electrical potential of a battery.
standard does not purport to address all of the safety concerns,
3.2.2 distributor, n—anypersonwhofurthersthemarketing
if any, associated with its use. It is the responsibility of the
of a device from the original manufacturer to the person who
users of this standard to consult and establish appropriate
makes final delivery or sale to the ultimate consumer or user
safety and health practices and determine the applicability of
but who does not repackage or otherwise change the container,
regulatory limitations prior to use.
wrapper, or labeling of the device or device package.
2. Referenced Documents 3.2.3 electronic thermometer, n—an instrument that pro-
vides a display of temperature sensed through the use of a
2.1 ASTM Standards:
transducer and electronic circuitry.
E344 Terminology Relating to Thermometry and Hydrom-
3.2.4 manufacturer, n—any person, including any repacker
etry
or relabeler, or both, who manufactures, fabricates, assembles,
E1104 Specification for ClinicalThermometer, Probe Cov-
2 or reprocesses a finished device. (See “Good Manufacturing
ers and Sheaths
Practices,” Part 807 Code of Federal Regulations 6.)
E1965 Specification for Infrared Thermometers for Inter-
2 3.2.5 measurement time, n—that time required from the
mittent Determination of Patient Temperature
time of patient contact to display of temperature to within the
2.2 Underwriters Laboratory Standards:
stated accuracy.
UL544 Standards for safety, medical and dental equipment
3.2.6 predictive thermometer, n—one that provides an indi-
UL 913 Standards for safety, intrinsically safe electrical
cation of the final stabilized temperature of the measurement
circuits and equipment for use in hazardous location
siteinadvanceofthetimenecessaryforthetransducertoreach
2.3 U.S. Pharmacopeia:
a stabilized temperature.
USP Latest Issue Biological Test
3.2.7 probe, n—an assembly, including the transducer, that
is used to position the transducer in the specific location at
which the temperature is to be determined.
3.2.8 probe cover and sheath, n—a device provided for the
This specification is under the jurisdiction of ASTM Committee E20 on purpose of preventing biological contact between the patient
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
and probe (see Specification E1104).
on Medical Thermometry.
3.2.9 IR thermometer, n—an optoelectronic instrument that
Current edition approved May 10, 2000. Published August 2000. Originally
is capable of noncontact infrared temperature measurement
published as E1112–86. Last previous edition E1112–98.
Annual Book of ASTM Standards, Vol 14.03.
Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara,
CA 92050.
4 5
Available from United States Pharmacopeia Convention, Inc.; 12601 Twin- Available from Superintendent of Documents, U. S. Government Printing
brook Parkway, Rockville MD 20852. Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E 1112
when placed into the auditory canal of a subject (ear canal °F. All full-degree graduations shall be long lines (see 4.4.1.3
type) or from the subject’s body surface (skin type). and 4.4.1.5). Half-degree graduations may be long lines. All
3.2.10 transducer, n—a device that provides a measurable other graduations shall be short lines. Appropriate numerals
output (for example, resistance, emf, etc.) as a function of shallbeplacedasaminimumateveryevendegreegraduation.
temperature. Graduation lines shall be spaced at least 0.55 mm (0.022 in.)
center to center.
4. Requirements
4.4.1.3 Scales Graduation Marks—All short graduation
4.1 Temperature range—As a minimum, the instrument
linesshallnotbelessthan1.3mm(0.05in.)inlength.Alllong
shalldisplaytemperatureoverthefollowingrange:35.5to41.0
graduation lines shall be no less than 25% longer than the
°C (96.0 to 106.0 °F).
short lines. The lines shall be essentially straight and in line
4.2 Accuracy—Within the manufacturer’s specified tem-
with the pointer. They shall not be wider than the spaces
perature range for patient temperature measurement, no indi-
between the graduations, nor wider than 0.45 mm (0.018 in.)
vidual reading shall be in error by more than the values shown
and shall not be narrower than 0.10 mm (0.004 in.).
in Table 1.
4.4.1.4 Pointer Width—The pointer shall have a maximum
4.3 Environment:
widthofone-halfofthespacingbetweengraduationmarks(see
4.3.1 Operating Environment—The instrument must meet
4.4.1.1 or 4.4.1.2).
the accuracy requirements of 4.2 when operated in an environ-
4.4.1.5 Reference Marking—The line at 37 °C (98.6 °F)
mentof16to40°C(60.8to104°F)andarelativehumidityof
may be designated by an arrow or other suitable mark. If a
15 to 95% noncondensing.
reference mark is used, the position shall be within a tolerance
4.3.2 Storage Environment—The instrument shall meet the
of one-half of the minimum graduated interval.
requirements of 4.2 after having been stored or transported, or
4.4.2 Digital Display:
both,atanypointinanenvironmentof−20to50°C(−4to120
4.4.2.1 Resolution—The digital display shall have incre-
°F), and a relative humidity of 15 to 95%, noncondensing, for
mental steps of not more than 0.1 °C or 0.1 °F.
a period of one month.
4.4.2.2 Readability—At the outside surface of the instru-
4.3.3 Labeling—The instruction manual shall include a
ment, the numerals shall appear to be at least 2.5 mm (0.1 in.)
statementthatinformstheuseriftheperformanceofthedevice
high and 1.5 mm (0.059 in.) wide and appear to be separated
may be degraded should one or more of the following occur:
from one another by a space of at least 0.7 mm (0.027 in.).
4.3.3.1 Operation outside the manufacturer’s stated tem-
4.5 Battery Condition—When battery operated, the instru-
perature and humidity range.
ment accuracy and condition shall not be affected by battery
4.3.3.2 Storage outside the manufacturer’s stated tempera-
condition unless a continuous automatic indication of unreli-
ture and humidity range.
able condition is provided. The indication of unreliable condi-
4.3.3.3 Mechanical shock (for example, drop test).
tion must be presented until the battery condition is corrected.
4.3.3.4 Patient temperature is below ambient temperature
When an instrument uses a rechargeable battery, a position
(operating environment see 4.3.1).
indication shall be provided with the instrument system to
4.4 Resolution:
indicate that the battery is charging.
4.4.1 Analog Display:
4.6 Construction:
4.4.1.1 CelsiusGraduations—Celsiusdisplaythermometers
4.6.1 Electrical—The instrument and accessories (such as
shall be graduated in intervals of not greater than 0.1 °C. All
battery chargers) shall meet the electrical safety requirements
full-degree graduations shall be long time. Half-degree gradu-
of UL 544 (see 5.3).
ations may be long lines. All other graduations shall be short
4.6.2 Material:
lines (see 4.4.1.3). As a minimum, appropriate numerals shall
4.6.2.1 Case Material—The case material of the instrument
be at every full-degree graduation except the numeral 37,
and nondisposable accessories shall withstand biological and
which is optional (see 4.4.1.5). Graduation lines shall be
physicalcleaningwithoutperformancedegradation(see5.2).It
spaced at least 0.50 mm (0.02 in.) center to center.
shall also withstand dropping without presenting an electrical
4.4.1.2 Fahrenheit Graduations—Fahrenheit display ther-
safety hazard.
mometersshallbegraduatedinintervalsofnotgreaterthan0.2
4.6.2.2 Patient Contact Materials—Those parts of the elec-
TABLE 1 Maximum Error Temperature Ranges
tronic thermometer system intended for contact with anatomi-
Temperature Maximum Error cal sites for the purpose of temperature measurement as
specified by the manufacturer shall be nontoxic (see 5.3).
Celsius Scale:
Less than 35.8°C 60.3°C
4.7 Marking—Allmarkingsforpurposesofidentificationor
35.8°C to less than 37°C 60.2°C
instruction must be clear and legible. Deterioration shall not
37.0°C to 39.0°C 60.1°C
Greater than 39.0°C to 41.0°C 60.2°C occur when subjected to cleaning (see 5.2).
Greater than 41.0°C 60.3°C
4.7.1 Instrument Marking—The instrument shall be marked
Fahrenheit Scale:
with the manufacturer’s or distributor’s name, model designa-
Less than 96.4°F 60.5°F
96.4°F to less than 98.0°F 60.3°F tion, serial number or lot number (to indicate the specific
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