ASTM E1112-00(2018)
(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 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 user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1112 −00 (Reapproved 2018)
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 E1965SpecificationforInfraredThermometersforIntermit-
tent Determination of Patient Temperature
1.1 This specification covers electronic instruments in-
2.2 Underwriters Laboratory Standards:
tended for intermittent monitoring of patient temperatures.
UL544StandardsforSafety,MedicalandDentalEquipment
1.2 Thisspecificationdoesnotcoverinfraredthermometers.
UL 913Standards for Safety, Intrinsically Safe Electrical
SpecificationE1965coversspecificationsforIRthermometers.
Circuits and Equipment for Use in Hazardous Location
1.3 The values stated in either SI units or inch-pound units
2.3 U.S. Pharmacopeia:
are to be regarded separately as standard. The values stated in
USP Latest Issue Biological Test
each system may not be exact equivalents; therefore, each
2.4 Federal Regulations:
system shall be used independently of the other. Combining
CFR Part 87Establishment Registration and Premarket No-
values from the two systems may result in non-conformance
tification Procedure
with the standard.
3. Terminology
1.4 The following precautionary caveat pertains only to the
test method portion, Section 5, of this specification. This
3.1 Definitions:
standard does not purport to address all of the safety concerns,
3.1.1 ThedefinitionsgiveninTerminologyE344shallapply
if any, associated with its use. It is the responsibility of the user
to this specification.
of this standard to establish appropriate safety, health, and
3.2 Definitions of Terms Specific to This Standard:
environmental practices and determine the applicability of
3.2.1 battery charger, n—electrical circuit designed to re-
regulatory limitations prior to use.
store the electrical potential of a battery.
1.5 This international standard was developed in accor-
3.2.2 distributor, n—any person who furthers the marketing
dance with internationally recognized principles on standard-
of a device from the original manufacturer to the person who
ization established in the Decision on Principles for the
makes final delivery or sale to the ultimate consumer or user
Development of International Standards, Guides and Recom-
but who does not repackage or otherwise change the container,
mendations issued by the World Trade Organization Technical
wrapper, or labeling of the device or device package.
Barriers to Trade (TBT) Committee.
3.2.3 electronic thermometer, n—instrument that provides a
display of temperature sensed through the use of a transducer
2. Referenced Documents
and electronic circuitry.
2.1 ASTM Standards:
3.2.4 manufacturer, n—any person, including any repacker
E344Terminology Relating to Thermometry and Hydrom-
or relabeler, or both, who manufactures, fabricates, assembles,
etry
or reprocesses a finished device. (See “Good Manufacturing
E1104Specification for ClinicalThermometer Probe Covers
Practices,” Part 807 Code of Federal Regulations 6.)
and Sheaths
3.2.5 measurementtime,n—thattimerequiredfromthetime
of patient contact to display of temperature to within the stated
accuracy.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.33 on Medical/Surgical Instruments.
Current edition approved Oct. 1, 2018. Published November 2018. Originally Available from Underwriters Laboratories (UL), 333 Pfingsten Rd.,
approved in 1986. Last previous edition approved in 2011 as E1112–00(2011). Northbrook, IL 60062-2096, http://www.ul.com.
DOI: 10.1520/E1112-00R18. Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or MD 20852-1790, http://www.usp.org.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Standards volume information, refer to the standard’s Document Summary page on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
the ASTM website. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1112 − 00 (2018)
3.2.6 predictive thermometer, n—one that provides an indi- 4.3.3.4 Patient temperature is below ambient temperature
cation of the final stabilized temperature of the measurement (operating environment see 4.3.1).
siteinadvanceofthetimenecessaryforthetransducertoreach
4.4 Resolution:
a stabilized temperature.
4.4.1 Analog Display:
3.2.7 probe, n—assembly, including the transducer, that is
4.4.1.1 Celsius Graduations—Celsius display thermometers
usedtopositionthetransducerinthespecificlocationatwhich
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
purpose of preventing biological contact between the patient lines (see 4.4.1.3). As a minimum, appropriate numerals shall
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.].
4.4.1.4 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 ReferenceMarking—Thelineat37°C[98.6°F]may
ment of 16 to 40°C [60.8 to 104°F] and a relative humidity of
bedesignatedbyanarroworothersuitablemark.Ifareference
15 to 95% noncondensing.
mark is used, the position shall be within a tolerance of
4.3.2 Storage Environment—The instrument shall meet the
one-half of the minimum graduated interval.
requirements of 4.2 after having been stored or transported, or
4.4.2 Digital Display:
both, at any point in an environment of −20 to 50°C [−4 to
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-
4.5 Battery Condition—When battery operated, the instru-
ture and humidity range.
ment accuracy and condition shall not be affected by battery
4.3.3.3 Mechanical shock (for example, drop test).
condition unless a continuous automatic indication of unreli-
able condition is provided. The indication of unreliable condi-
TABLE 1 Maximum Error Temperature Ranges
tion must be presented until the battery condition is corrected.
Temperature Maximum Error
When an instrument uses a rechargeable battery, a position
Celsius Scale:
indication shall be provided with the instrument system to
Less than 35.8°C ±0.3°C
indicate that the battery is charging.
35.8°C to less than 37°C ±0.2°C
37.0°C to 39.0°C ±0.1°C
4.6 Construction:
Greater than 39.0°C to 41.0°C ±0.2°C
Greater than 41.0°C ±0.3°C
4.6.1 Electrical—The instrument and accessories (such as
Fahrenheit Scale:
battery chargers) shall meet the electrical safety requirements
Less than 96.4°F ±0.5°F
of UL 544 (see 5.3).
96.4°F to less than 98.0°F ±0.3°F
98.0°F to 102.0°F ±0.2°F
4.6.2 Material:
Greater than 102.0°F to 106.0°F ±0.3°F
4.6.2.1 Case Material—The case material of the instrument
Greater than 106.0°F ±0.5°F
and nondisposable accessories shall withstand biological and
E1112 − 00 (2018)
physicalcleaningwithoutperformancedegradation(see5.2).It 4.8.2 Service and Repair Manual—A service manual
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