ASTM E1965-98(2003)
(Specification)Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
ABSTRACT
This specification covers infrared thermometers, which are electronic instruments intended for the intermittent measurement and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. The specification addresses the assessment of the subject's internal body temperature through measurement of thermal emission from the ear canal. Though, performance requirements for noncontact temperature measurement of skin are also provided. Limits are set for laboratory accuracy, and determination and disclosure of clinical accuracy of the covered instruments are required. Performance and storage limits under various environmental conditions, requirements for labeling, and test procedures are all established herein.
SCOPE
1.1 This specification covers electronic instruments intended for intermittent measuring and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor.
1.2 The specification addresses assessing subject's body internal temperature through measurement of thermal emission from the ear canal. Performance requirements for noncontact temperature measurement of skin are also provided.
1.3 The specification sets limits for laboratory accuracy and requires determination and disclosure of clinical accuracy of the covered instruments.
1.4 Performance and storage limits under various environmental conditions, requirements for labeling and test procedures are established.
Note 1—For electrical safety consult Underwriters Laboratory Standards.
Note 2—For electromagnetic emission requirements and tests refer to CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment.
1.5 The values of quantities stated in SI units are to be regarded as the standard. The values of quantities in parentheses are not in SI and are optional.
1.6 The following precautionary 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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Standards Content (Sample)
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Designation: E 1965 – 98 (Reapproved 2003)
Standard Specification for
Infrared Thermometers for Intermittent Determination of
Patient Temperature
This standard is issued under the fixed designation E 1965; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
1.1 This specification covers electronic instruments in- 2.1 ASTM Standards:
tended for intermittent measuring and monitoring of patient E 177 Practice for Use of the Terms Precision and Bias in
temperatures by means of detecting the intensity of thermal ASTM Test Methods
radiation between the subject of measurement and the sensor. E 344 Terminology Relating to Thermometry and Hydrom-
1.2 The specification addresses assessing subject’s body etry
internal temperature through measurement of thermal emission E 667 Specification for Mercury-in-Glass Maximum Self-
from the ear canal. Performance requirements for noncontact Registering Clinical Thermometers
temperature measurement of skin are also provided. E 1112 Specification for ElectronicThermometers for Inter-
1.3 The specification sets limits for laboratory accuracy and mittent Determination of Patient Temperature
requires determination and disclosure of clinical accuracy of 2.2 International Electrotechnical Commission Standards:
the covered instruments. IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1;
1.4 Performance and storage limits under various environ- General Requirements for Safety. Collateral Standard:
mental conditions, requirements for labeling and test proce- Electromagnetic Compatibility—Requirements and Tests
dures are established. IEC 1000-4-2: 1995 Electromagnetic Compatibility
(EMC)—Part 4: Testing and Measurement Techniques;
NOTE 1—For electrical safety consult Underwriters Laboratory Stan-
2 Section 2: Electrostatic Discharge Immunity Test: Basic
dards .
EMC Publication (Rev. of IEC 801-2)
NOTE 2—For electromagnetic emission requirements and tests refer to
CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic IEC 1000-4-3: 1995 Electromagnetic Compatibility
Disturbance Characteristics of Industrial, Scientific, and Medical (ISM)
2.3 Other Standards:
Radiofrequency Equipment .
International Vocabulary of Basic and General Terms in
Metrology (VIM)
1.5 The values of quantities stated in SI units are to be
regarded as the standard. The values of quantities in parenthe-
3. Terminology
ses are not in SI and are optional.
3.1 Definitions—The definitions given in Terminology
1.6 The following precautionary caveat pertains only to the
E 344 apply.
test method portion, Section 6, of this specification: This
3.2 Definitions of Terms Specific to This Standard—The
standard does not purport to address all of the safety concerns,
terms defined below are for the purposes of this specification
if any, associated with its use. It is the responsibility of the user
only. Manufacturers should use this terminology in labeling
of this standard to establish appropriate safety and health
instruments and in technical and sales literature.
practices and determine the applicability of regulatory limita-
3.2.1 accuracy, n—ability of an infrared thermometer to
tions prior to use.
give a reading close to the true temperature.
3.2.2 adjusted mode, n—output of an IR thermometer that
gives temperature measured and calculated from a subject or
This specification is under the jurisdiction of ASTM Committee E20 on
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
object, by correcting such temperature for variations in ambi-
on Medical Thermometry.
ent temperature, subject’s temperature, emissivity, body site
Current edition approved May 10, 2003. Published July 2003. Originally
(that is, oral,or rectal), etc.
approved in 1998. Last previous edition approved in 1998 as E 1965 – 98.
Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara,
CA 95050.
3 4
Available from Global Engineering Documents, 15 Inverness Way East, Annual Book of ASTM Standards, Vol 14.02.
Englewood, CO 80112. Annual Book of ASTM Standards, Vol 14.03.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E 1965 – 98 (2003)
3.2.3 axillary temperature [t ], n—temperature at the apex 3.2.19 infrared (IR), adj—of the electromagnetic radiation
ba
of either axilla (armpit) as measured by a contact thermometer. within the mid- and far infrared spectral ranges (approximately
from 3 to 30 µm wavelength).
3.2.4 blackbody, n—a reference source of infrared radiation
made in the shape of a cavity and characterized by precisely
3.2.20 infrared (IR) thermometer, n—optoelectronic instru-
known temperature of the cavity walls and having effective ment adapted for noncontact measurement of temperature of a
emissivity at the cavity opening arbitrarily considered equal to
subject by utilizing infrared radiation exchange between the
unity. subject and the sensor.
3.2.5 blackbody temperature [t ], n—temperature of
3.2.21 instrumentational offset [µ ], n—calculated differ-
BB
d
blackbody cavity walls as measured by an imbedded or
ence in degrees of measured temperature between core tem-
immersed contact thermometer.
perature and ear canal temperature, derived from the popula-
3.2.6 bladder temperature, n—temperatureoftheinteriorof tion of representative study samples.
urinary bladder as measured by a contact thermometer.
3.2.22 internal, adj—of the interior of subject’s body or
3.2.7 body temperature, n—temperature measured from the
body cavity, such as pulmonary artery, urinary bladder, oral,
interior of a human body cavity, such as pulmonary artery,
rectal, etc.
distal esophagus, urinary bladder, ear canal, oral, or rectal.
3.2.23 laboratory error [d], n—difference between unad-
3.2.8 clinical accuracy, n—ability of an infrared ear canal
justed temperature as measured by an IR thermometer and
thermometer to give a reading close to true temperature of the
temperature of a blackbody, over specified operating condi-
site that it purports to represent.
tions of ambient temperature and humidity and blackbody
3.2.9 clinical bias [x¯ ], n—mean difference between IR
temperature ranges.
d
thermometer output and an internal body site temperature from
3.2.24 operating temperature, n—ambient temperature that
subjects at specified conditions of ambient temperature and
allows operation of an IR thermometer within specified labo-
humidity and averaged over a selected group of subjects.
ratory error range.
3.2.10 clinical repeatability [s ], n—pooled standard devia-
r 3.2.25 operating humidity, n—relative humidity of ambient
tion of changes in multiple ear canal temperature readings as
air which allows operation of an IR thermometer within a
taken from the same subject from the same ear with the same
specified laboratory error range.
infrared thermometer by the same operator within a relatively
3.2.26 oral temperature [t ], n—posterior sublingual tem-
bm
short time.
perature as measured by a contact thermometer.
3.2.11 combined site offset [µ ], n—calculated difference in
s
3.2.27 physiological site offset, [µ ], n—difference in de-
p
degrees of measured temperature between a selected reference
grees of measured temperature between two body sites derived
body site and ear canal temperature and averaged over the
from the representative study samples.
population of representative study samples.
3.2.28 probe, n—part of an IR thermometer that channels
3.2.12 contact thermometer, n—an instrument that is
net infraredradiationbetweenthe subjectandthe sensorandis
adapted for measuring temperature by means of thermal
intended to be positioned near or inside the subject.
conductivity by determining temperature at the moment when
3.2.29 probe cover, n—disposable or reusable sanitary bar-
negligible thermal energy flows between the thermometer and
rier enveloping that part of the probe which otherwise would
the object of measurement.
come in contact with a subject.
3.2.13 core temperature [t ], n—temperature at a subject’s
c
3.2.30 professional use, n—intended or implied use of an
body site, such as pulmonary artery, distal esophagus, urinary
instrument by individuals that are licensed or certified for
bladder, or tympanic membrane, recognized as indicative of
collecting information for medical diagnosing purposes.
internal body temperature and obtained with a contact ther-
3.2.31 rectal temperature [t ], n—temperature in the anal
br
mometer.
canal as measured by a contact thermometer.
3.2.14 mode, n—an output of an IR thermometer that gives
3.2.32 resolution, n—minimum temperature increment dis-
a representation of a temperature using a disclosed calculation
played by an IR thermometer in degrees Celsius or Fahrenheit.
technique with respect to selected reference (for example,
3.2.33 scale, n—graduation of temperature display in de-
blackbody, oral, rectal, etc.).
grees Celsius or Fahrenheit.
3.2.15 displayed temperature range, n—temperature range
3.2.34 sensor, n—device designed to respond to net IR
in degrees Celsius or Fahrenheit that can be shown by an IR
radiation and convert that response into electrical signals.
thermometer.
3.2.35 skin temperature, n—average temperature of a flat
3.2.16 IR thermometer type, n—an optoelectronic instru-
skin surface as measured from the field of view of an IR skin
ment that is capable of noncontact infrared temperature mea-
type thermometer, with an appropriate adjustments for skin
surement when placed into the auditory canal of a subject (ear
emissivity.
canal type) or from the subject’s body surface (skin type).
3.2.36 system, n—combinationofan IR thermometerandan
3.2.17 ear canal temperature [t ], n—displayed unadjusted
ec
installed probe cover.
temperature measured from the field of view of an IR thermom-
3.2.37 subject, n—ahumanwhosetemperatureismeasured.
eter whose probe is placed into the auditory canal of a subject
according to the manufacturer’s recommendations.
3.2.38 true temperature, n—temperature attributed to a
3.2.18 field of view, n—area of a subject’s surface that particular site of a subject or object of measurement and
exchanges thermal radiation with the sensor. accepted as having a specified uncertainty.
E 1965 – 98 (2003)
3.2.39 tympanic temperature [t ], n—temperature of either 5.6 Ambient Conditions:
ty
tympanic membrane as measured by a contact thermometer.
5.6.1 Operating Temperature Range:
3.2.40 unadjusted mode, n—an output of IR thermometer
5.6.1.1 The system shall meet laboratory error requirements
that displays temperature measured and calculated from a
as specified in 5.3 or 5.4, or both, when operating in an
subject or object, without any corrections for variations in
environment from 16 to 40 °C (60.8 to 104.0 °F).
operating temperature, subject temperature, emissivity, etc.
5.6.1.2 If the operating temperature range is narrower than
specified in 5.6.1.1, the device shall be clearly labeled with a
4. Classification
cautionary statement of the maximum or minimum operating
4.1 IR thermometers may be classified into two types: “ear
temperatures, or both.
canal IR thermometers” and “skin IR thermometers.”
5.6.1.3 Under no circumstances may the upper limit of
4.1.1 TheearcanalIRthermometerisintendedforassessing
operating temperature range be less than 35 °C (95 °F).
the internal temperature of a subject.
5.6.2 Operating Humidity Range—The relative humidity
4.1.2 The skin IR thermometer is intended for assessing the
range for the operating temperature range as specified in 5.6.1
outer surface temperature of a subject.
is up to 95 %, noncondensing.
5. Requirements
5.6.3 Shock:
5.1 The following requirements shall apply to any IR
5.6.3.1 The instrument with batteries installed (if appli-
thermometer that is labeled to meet these specifications.
cable)withoutacarrying(storage)casingshallwithstanddrops
5.2 Displayed Temperature Range:
withcontrolledorientationofthedevicewithoutdegradationof
5.2.1 In any display mode, an ear canal IR thermometer
accuracy as specified in 5.3 or 5.4, or both, for a blackbody
shall display a subject’s temperature over a minimum range of
temperature of or near 37 °C (98.6 °F), when tested according
34.4 to 42.2 ° C (94.0 to 108.0 °F).
to 6.3.
5.2.2 A skin IR thermometer shall display a subject’s
5.6.3.2 If an IR thermometer does not meet requirement of
temperature over a minimum range of 22 to 40.0 °C (71.6 to
5.6.3.1, a means of detecting and informing the user of its
104.0 °F).
inoperable state, after being subjected to shock, shall be
5.3 Maximum Permissible Laboratory Error (for an Ear
provided.
Canal IR Thermometer):
5.6.4 Storage Conditions—The instrument shall meet the
5.3.1 Withinthemanufacturer’sspecifiedoperatingambient
accuracy requirements of 5.3 or 5.4, or both, after having been
conditions (see 5.6), laboratory error d as measured according
stored or transported, or both, at any point in an environment
to 6.1.4 shall be no greater than values specified below:
of – 20 to + 50 °C (– 4 to + 122 °F) and relative humidity up
5.3.1.1 For blackbody temperature range from 36 to 39 °C
to 95 %, noncondensing, for a period of one month. The test
(96.8 to 102.2 °F)
procedure is specified in 6.1.6.
0.2 °C (0.4 °F).
5.6.5 Cleaning and Disinfection—Instrument performance
5.3.1.2 For blackbody temperatures less than 36 °C (96.8
shall not be degraded by using the manufacturer’s recom-
°F) or greater than 39 °C (102.2 °F)
mended procedures for cleaning and disinfection provided in
0.3 °C (0.5 ° F).
the instruction manual. Such procedures are part of the
5.4 Maximum Permissible Laboratory Error (for a Skin IR
required documentation in 7.2.2.
Thermometer):
5.6.6 Electromagnetic Immunity—An IR thermometer that
5.4.1 Withinthemanufacturer’sspecifiedoperatingambient
conditions (see 5.6) over the display temperature range as is intended for professional use shall meet the accuracy
requirements of 5.3 or 5.4, or both, for temperature ranges of
specified in 5.2.2, laboratory error d as measured according to
6.1.5 shall be no greater than 0.3 °C (0.5 °F). 6.3.2, during and after exposure to electromagnetic interfer-
ence.
5.5 Special Requirements:
5.5.1 Clinical Accuracy:
5.6.7 Electrostatic Discharge—An IR thermometer shall
5.5.1.1 The clinical accuracy requirement is applicable only
meet the accuracy requirements of 5.3 and 5.4, or both, for
to an ear canal IR thermometer system and the corresponding
temperature ranges of 6.3.2, after 5 s from bei
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