ASTM E1112-00(2006)
(Specification)Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
ABSTRACT
This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. The temperature range of the instrument shall display temperature within the specific range requirement and regards to its accuracy, no individual reading shall be in error by more than the values that are determined. The operating environment must meet the determined accuracy requirements when operated in an environment of a certain temperature and also with a certain relative humidity. The resolutions of analog display such as Celsius graduations, Fahrenheit graduations, scale graduation marks and pointer width shall also be observed. Its digital display shall conform to the standard resolution, readability and buttery condition of the material. The case material of the instrument and non disposable accessories shall withstand biological and physical cleaning without performance degradation. It shall also withstand dropping without presenting an electrical safety hazard. Those parts of the electronic thermometer system intended for contact with anatomical sites for the purpose of temperature measurement as specified by the manufacturer shall be also be nontoxic. The following tests shall be conducted in order to determine the instrument's performance: cleaning test, toxicity test, and accuracy test.
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 E 1965 covers specifications for IR thermometers.
1.3 The values stated in SI units are to be regarded as the standard.
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 concerns, 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: E1112 – 00 (Reapproved 2006)
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 (´) 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
SpecificationE1965coversspecificationsforIRthermometers.
3.1 Definitions:
1.3 The values stated in SI units are to be regarded as the
3.1.1 ThedefinitionsgiveninTerminologyE344shallapply
standard.
to this specification.
1.4 The following precautionary caveat pertains only to the
3.2 Definitions of Terms Specific to This Standard:
test method portion, Section 5, of this specification. This
3.2.1 battery charger, n—electrical circuit designed to re-
standard does not purport to address all of the safety concerns,
store the electrical potential of a battery.
if any, associated with its use. It is the responsibility of the
3.2.2 distributor, n—anypersonwhofurthersthemarketing
users of this standard to consult and establish appropriate
of a device from the original manufacturer to the person who
safety and health practices and determine the applicability of
makes final delivery or sale to the ultimate consumer or user
regulatory limitations prior to use.
butwhodoesnotrepackageorotherwisechangethecontainer,
2. Referenced Documents wrapper, or labeling of the device or device package.
3.2.3 electronic thermometer, n—instrumentthatprovidesa
2.1 ASTM Standards:
display of temperature sensed through the use of a transducer
E344 Terminology Relating to Thermometry and Hydrom-
and electronic circuitry.
etry
3.2.4 manufacturer, n—any person, including any repacker
E1104 Specification for Clinical Thermometer Probe Cov-
or relabeler, or both, who manufactures, fabricates, assembles,
ers and Sheaths
or reprocesses a finished device. (See “Good Manufacturing
E1965 Specification for Infrared Thermometers for Inter-
Practices,” Part 807 Code of Federal Regulations 6.)
mittent Determination of Patient Temperature
3 3.2.5 measurement time, n—that time required from the
2.2 Underwriters Laboratory Standards:
time of patient contact to display of temperature to within the
UL 544 Standards for Safety, Medical and Dental Equip-
stated accuracy.
ment
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—assembly, including the transducer, that is
usedtopositionthetransducerinthespecificlocationatwhich
the temperature is to be determined.
This specification is under the jurisdiction of ASTM Committee F04 on
3.2.8 probe cover and sheath, n—device provided for the
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.33 on Medical/Surgical Instruments. purpose of preventing biological contact between the patient
Current edition approved May 1, 2006. Published May 2006. Originally
and probe (see Specification E1104).
approved in 1986. Last previous edition approved in 2000 as E1112–00. DOI:
3.2.9 IR thermometer, n—optoelectronic instrument that is
10.1520/E1112-00R06.
capableofnoncontactinfraredtemperaturemeasurementwhen
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
placed into the auditory canal of a subject (ear canal type) or
Standards volume information, refer to the standard’s Document Summary page on
from the subject’s body surface (skin type).
the ASTM website.
Available from Underwriters Laboratories (UL), Corporate Progress, 333
Pfingsten Rd., Northbrook, IL 60062.
4 5
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E1112 – 00 (2006)
3.2.10 transducer, n—device that provides a measurable and 4.4.1.5). Half-degree graduations may be long lines. All
output (for example, resistance, emf, etc.) as a function of other graduations shall be short lines. Appropriate numerals
temperature. shallbeplacedasaminimumateveryevendegreegraduation.
Graduation lines shall be spaced at least 0.55 mm (0.022 in.)
4. Requirements
center to center.
4.1 Temperature range—As a minimum, the instrument 4.4.1.3 Scales Graduation Marks—All short graduation
shalldisplaytemperatureoverthefollowingrange:35.5to41.0
linesshallnotbelessthan1.3mm(0.05in.)inlength.Alllong
°C (96.0 to 106.0 °F). graduation lines shall be no less than 25% longer than the
4.2 Accuracy—Within the manufacturer’s specified tem-
short lines. The lines shall be essentially straight and in line
perature range for patient temperature measurement, no indi- with the pointer. They shall not be wider than the spaces
vidual reading shall be in error by more than the values shown
between the graduations, nor wider than 0.45 mm (0.018 in.)
in Table 1. and shall not be narrower than 0.10 mm (0.004 in.).
4.3 Environment:
4.4.1.4 Pointer Width—The pointer shall have a maximum
4.3.1 Operating Environment—The instrument must meet
widthofone-halfofthespacingbetweengraduationmarks(see
the accuracy requirements of 4.2 when operated in an environ-
4.4.1.1 or 4.4.1.2).
mentof16to40°C(60.8to104°F)andarelativehumidityof
4.4.1.5 Reference Marking—The line at 37 °C (98.6 °F)
15 to 95% noncondensing.
may be designated by an arrow or other suitable mark. If a
4.3.2 Storage Environment—The instrument shall meet the
reference mark is used, the position shall be within a tolerance
requirements of 4.2 after having been stored or transported, or
of one-half of the minimum graduated interval.
both,atanypointinanenvironmentof−20to50°C(−4to120
4.4.2 Digital Display:
°F), and a relative humidity of 15 to 95%, noncondensing, for
4.4.2.1 Resolution—The digital display shall have incre-
a period of one month.
mental steps of not more than 0.1 °C or 0.1 °F.
4.3.3 Labeling—The instruction manual shall include a
4.4.2.2 Readability—At the outside surface of the instru-
statementthatinformstheuseriftheperformanceofthedevice
ment, the numerals shall appear to be at least 2.5 mm (0.1 in.)
may be degraded should one or more of the following occur:
high and 1.5 mm (0.059 in.) wide and appear to be separated
4.3.3.1 Operation outside the manufacturer’s stated tem-
from one another by a space of at least 0.7 mm (0.027 in.).
perature and humidity range.
4.5 Battery Condition—When battery operated, the instru-
4.3.3.2 Storage outside the manufacturer’s stated tempera-
ment accuracy and condition shall not be affected by battery
ture and humidity range.
condition unless a continuous automatic indication of unreli-
4.3.3.3 Mechanical shock (for example, drop test).
able condition is provided. The indication of unreliable condi-
4.3.3.4 Patient temperature is below ambient temperature
tion must be presented until the battery condition is corrected.
(operating environment see 4.3.1).
When an instrument uses a rechargeable battery, a position
4.4 Resolution:
indication shall be provided with the instrument system to
4.4.1 Analog Display:
indicate that the battery is charging.
4.4.1.1 Celsius Graduations—Celsiusdisplaythermometers
4.6 Construction:
shall be graduated in intervals of not greater than 0.1 °C. All
full-degree graduations shall be long time. Half-degree gradu- 4.6.1 Electrical—The instrument and accessories (such as
ations may be long lines. All other graduations shall be short
battery chargers) shall meet the electrical safety requirements
lines (see 4.4.1.3). As a minimum, appropriate numerals shall of UL544 (see 5.3).
be at every full-degree graduation except the numeral 37,
4.6.2 Material:
which is optional (see 4.4.1.5). Graduation lines shall be
4.6.2.1 Case Material—The case material of the instrument
spaced at least 0.50 mm (0.02 in.) center to center.
and nondisposable accessories shall withstand biological and
4.4.1.2 Fahrenheit Graduations—Fahrenheit display ther-
physicalcleaningwithoutperformancedegradation(see5.2).It
mometersshallbegraduatedinintervalsofnotgreaterthan0.2
shall also withstand dropping without presenting an electrical
°F. All full-degree graduations shall be long lines (see 4.4.1.3
safety hazard.
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-
cal sites for the purpose of temperature measurement as
Temperature Maximum Error
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°Cto39.0°C 60.1 °C
occur when subjected to cleaning (see 5.2).
Greater than 39.0 °C to 41.0 °C 60.2 °C
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 t
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