ASTM E1112-00(2011)
(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 battery 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 E1965 covers specifications for IR thermometers.
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with 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 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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Standards Content (Sample)
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Designation:E1112 −00(Reapproved 2011)
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 UL 913Standards for Safety, Intrinsically Safe Electrical
Circuits and Equipment for Use in Hazardous Location
1.1 This specification covers electronic instruments in-
tended for intermittent monitoring of patient temperatures. 2.3 U.S. Pharmacopeia:
USP Latest Issue Biological Test
1.2 Thisspecificationdoesnotcoverinfraredthermometers.
SpecificationE1965coversspecificationsforIRthermometers. 2.4 Federal Regulations:
CFR Part 87Establishment Registration and Premarket No-
1.3 The values stated in either SI units or inch-pound units
tification Procedure
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each
3. Terminology
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance
3.1 Definitions:
with the standard. 3.1.1 ThedefinitionsgiveninTerminologyE344shallapply
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
users of this standard to consult and establish appropriate
3.2.2 distributor, n—any person who furthers the marketing
safety and health practices and determine the applicability of of a device from the original manufacturer to the person who
regulatory limitations prior to use. makes final delivery or sale to the ultimate consumer or user
but who does not repackage or otherwise change the container,
2. Referenced Documents wrapper, or labeling of the device or device package.
3.2.3 electronic thermometer, n—instrument that provides a
2.1 ASTM Standards:
display of temperature sensed through the use of a transducer
E344Terminology Relating to Thermometry and Hydrom-
and electronic circuitry.
etry
E1104Specification for ClinicalThermometer Probe Covers
3.2.4 manufacturer, n—any person, including any repacker
and Sheaths
or relabeler, or both, who manufactures, fabricates, assembles,
E1965SpecificationforInfraredThermometersforIntermit-
or reprocesses a finished device. (See “Good Manufacturing
tent Determination of Patient Temperature
Practices,” Part 807 Code of Federal Regulations 6.)
2.2 Underwriters Laboratory Standards:
3.2.5 measurementtime,n—thattimerequiredfromthetime
UL544StandardsforSafety,MedicalandDentalEquipment
of patient contact to display of temperature to within the stated
accuracy.
3.2.6 predictive thermometer, n—one that provides an indi-
This specification is under the jurisdiction of ASTM Committee F04 on
cation of the final stabilized temperature of the measurement
Medical and Surgical Materials and Devices and is the direct responsibility of
siteinadvanceofthetimenecessaryforthetransducertoreach
Subcommittee F04.33 on Medical/Surgical Instruments.
a stabilized temperature.
Current edition approved June 1, 2011. Published June 2011. Originally
approved in 1986. Last previous edition approved in 2006 as E1112–00 (2006).
DOI: 10.1520/E1112-00R11.
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 Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
Standards volume information, refer to the standard’s Document Summary page on MD 20852-1790, http://www.usp.org.
the ASTM website. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
Northbrook, IL 60062-2096, http://www.ul.com. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1112−00(2011)
3.2.7 probe, n—assembly, including the transducer, that is 4.4.1.1 Celsius Graduations—Celsius display thermometers
usedtopositionthetransducerinthespecificlocation at which shall be graduated in intervals of not greater than 0.1°C. All
the temperature is to be determined. full-degree graduations shall be long time. Half-degree gradu-
ations may be long lines. All other graduations shall be short
3.2.8 probe cover and sheath, n—device provided for the
lines (see 4.4.1.3). As a minimum, appropriate numerals shall
purpose of preventing biological contact between the patient
be at every full-degree graduation except the numeral 37,
and probe (see Specification E1104).
which is optional (see 4.4.1.5). Graduation lines shall be
3.2.9 IR thermometer, n—optoelectronic instrument that is
spaced at least 0.50 mm [0.02 in.] center to center.
capableofnoncontactinfraredtemperaturemeasurementwhen
4.4.1.2 Fahrenheit Graduations—Fahrenheit display ther-
placed into the auditory canal of a subject (ear canal type) or
mometers shall be graduated in intervals of not greater than
from the subject’s body surface (skin type).
0.2°F. All full-degree graduations shall be long lines (see
3.2.10 transducer, n—device that provides a measurable
4.4.1.3 and 4.4.1.5). Half-degree graduations may be long
output (for example, resistance, emf, etc.) as a function of
lines. All other graduations shall be short lines. Appropriate
temperature.
numerals shall be placed as a minimum at every even degree
graduation. Graduation lines shall be spaced at least 0.55 mm
4. Requirements
[0.022 in.] center to center.
4.1 Temperature range—As a minimum, the instrument
4.4.1.3 Scales Graduation Marks—All short graduation
shall display temperature over the following range: 35.5 to
linesshallnotbelessthan1.3mm[0.05in.]inlength.Alllong
41.0°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).
ment of 16 to 40°C [60.8 to 104°F] and a relative humidity of
4.4.1.5 ReferenceMarking—Thelineat37°C[98.6°F]may
15 to 95% noncondensing.
bedesignatedbyanarroworothersuitablemark.Ifareference
4.3.2 Storage Environment—The instrument shall meet the
mark is used, the position shall be within a tolerance of
requirements of 4.2 after having been stored or transported, or
one-half of the minimum graduated interval.
both, at any point in an environment of −20 to 50°C [−4 to
4.4.2 Digital Display:
120°F], and a relative humidity of 15 to 95%, noncondensing,
4.4.2.1 Resolution—The digital display shall have incre-
for 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
statementthatinformstheuseriftheperformanceofthedevice
instrument,thenumeralsshallappeartobeatleast2.5mm[0.1
may be degraded should one or more of the following occur:
in.] high and 1.5 mm [0.059 in.] wide and appear to be
4.3.3.1 Operation outside the manufacturer’s stated tem-
separated from one another by a space of at least 0.7 mm
perature and humidity range.
[0.027 in.].
4.3.3.2 Storage outside the manufacturer’s stated tempera-
ture and humidity range.
4.5 Battery Condition—When battery operated, the instru-
4.3.3.3 Mechanical shock (for example, drop test).
ment accuracy and condition shall not be affected by battery
4.3.3.4 Patient temperature is below ambient temperature
condition unless a continuous automatic indication of unreli-
(operating environment see 4.3.1).
able condition is provided. The indication of unreliable condi-
tion must be presented until the battery condition is corrected.
4.4 Resolution:
When an instrument uses a rechargeable battery, a position
4.4.1 Analog Display:
indication shall be provided with the instrument system to
indicate that the battery is charging.
TABLE 1 Maximum Error Temperature Ranges
Temperature Maximum Error
4.6 Construction:
Celsius Scale:
4.6.1 Electrical—The instrument and accessories (such as
Less than 35.8°C ±0.3°C
35.8°C to less than 37°C ±0.2°C
battery chargers) shall meet the electrical safety requirements
37.0°C to 39.0°C ±0.1°C
of UL 544 (see 5.3).
Greater than 39.0°C to 41.0°C ±0.2°C
Greater than 41.0°C ±0.3°C
4.6.2 Material:
Fahrenheit Scale:
4.6.2.1 Case Material—The case material of the instrument
Less than 96.4°F ±0.5°F
96.4°F to less than 98.0°F ±0.3°F and nondisposable accessories shall withstand biological and
98.0°F to 102.0°F ±0.2°F
physicalcleaningwithoutperformancedegradation(see5.2).It
Greater than 102.0°F to 106.0°F ±0.3°F
shall also withstand dropping without presenting an electrical
Greater than 106.0°F ±0.5°F
safety hazard.
E1112−00(2011)
4.6.2.2 Patient Contact Materials—Those parts of the elec- maintenance information, test procedures, test equipment
tronic thermometer system intended for contact with anatomi- requ
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