ASTM E1965-98(2009)
(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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Designation:E1965 −98(Reapproved 2009)
Standard Specification for
Infrared Thermometers for Intermittent Determination of
Patient Temperature
This standard is issued under the fixed designation E1965; 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
2.1 ASTM Standards:
1.1 This specification covers electronic instruments in-
E177 Practice for Use of the Terms Precision and Bias in
tended for intermittent measuring and monitoring of patient
ASTM Test Methods
temperatures by means of detecting the intensity of thermal
E344 Terminology Relating to Thermometry and Hydrom-
radiation between the subject of measurement and the sensor.
etry
1.2 The specification addresses assessing subject’s body
E667 Specification for Mercury-in-Glass, Maximum Self-
internal temperature through measurement of thermal emission
Registering Clinical Thermometers
from the ear canal. Performance requirements for noncontact
E1112 Specification for Electronic Thermometer for Inter-
temperature measurement of skin are also provided.
mittent Determination of Patient Temperature
1.3 The specification sets limits for laboratory accuracy and
2.2 International Electrotechnical Commission Standards:
requires determination and disclosure of clinical accuracy of
IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1;
the covered instruments.
General Requirements for Safety. Collateral Standard:
Electromagnetic Compatibility—Requirements and Tests
1.4 Performance and storage limits under various environ-
IEC 1000-4-2: 1995 Electromagnetic Compatibility
mental conditions, requirements for labeling and test proce-
(EMC)—Part 4: Testing and Measurement Techniques;
dures are established.
Section 2: Electrostatic Discharge Immunity Test: Basic
NOTE 1—For electrical safety consult Underwriters Laboratory Stan-
EMC Publication (Rev. of IEC 801-2)
dards.
NOTE 2—For electromagnetic emission requirements and tests refer to IEC 1000-4-3: 1995 Electromagnetic Compatibility
CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic
2.3 Other Standards:
Disturbance Characteristics of Industrial, Scientific, and Medical (ISM)
International Vocabulary of Basic and General Terms in
Radiofrequency Equipment.
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—ThedefinitionsgiveninTerminologyE344
1.6 The following precautionary caveat pertains only to the apply.
test method portion, Section 6, of this specification: This
3.2 Definitions of Terms Specific to This Standard:
standard does not purport to address all of the safety concerns,
3.2.1 The terms defined below are for the purposes of this
if any, associated with its use. It is the responsibility of the user
specification only. Manufacturers should use this terminology
of this standard to establish appropriate safety and health
in labeling instruments and in technical and sales literature.
practices and determine the applicability of regulatory limita-
3.2.2 accuracy, n—ability of an infrared thermometer to
tions prior to use.
give a reading close to the true temperature.
3.2.3 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 F04 on
object, by correcting such temperature for variations in ambi-
Medical and Surgical Materials and Devices and is the direct responsibility of
ent temperature, subject’s temperature, emissivity, body site
Subcommittee F04.33 on Medical/Surgical Instruments.
(that is, oral,or rectal), etc.
CurrenteditionapprovedMay1,2009.PublishedJuly2009.Originallyapproved
in 1998. Last previous edition approved in 2003 as E1965 – 98 (2003). DOI:
10.1520/E1965-98R09.
2 4
Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara, For referenced ASTM standards, visit the ASTM website, www.astm.org, or
CA 95050. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Available from Global Engineering Documents, 15 Inverness Way East, Standards volume information, refer to the standard’s Document Summary page on
Englewood, CO 80112. the ASTM website.
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E1965−98 (2009)
3.2.4 axillary temperature [t ], n—temperature at the apex eter whose probe is placed into the auditory canal of a subject
ba
of either axilla (armpit) as measured by a contact thermometer. according to the manufacturer’s recommendations.
3.2.19 field of view, n—area of a subject’s surface that
3.2.5 blackbody, n—a reference source of infrared radiation
exchanges thermal radiation with the sensor.
made in the shape of a cavity and characterized by precisely
known temperature of the cavity walls and having effective
3.2.20 infrared (IR), adj—of the electromagnetic radiation
emissivity at the cavity opening arbitrarily considered equal to
within the mid- and far infrared spectral ranges (approximately
unity.
from 3 to 30 µm wavelength).
3.2.6 blackbody temperature [t ], n—temperature of 3.2.21 infrared (IR) thermometer, n—optoelectronic instru-
BB
blackbody cavity walls as measured by an imbedded or ment adapted for noncontact measurement of temperature of a
immersed contact thermometer. subject by utilizing infrared radiation exchange between the
subject and the sensor.
3.2.7 bladder temperature, n—temperature of the interior of
3.2.22 instrumentational offset [µ ], n—calculated differ-
urinary bladder as measured by a contact thermometer.
d
ence in degrees of measured temperature between core tem-
3.2.8 body temperature, n—temperature measured from the
perature and ear canal temperature, derived from the popula-
interior of a human body cavity, such as pulmonary artery,
tion of representative study samples.
distal esophagus, urinary bladder, ear canal, oral, or rectal.
3.2.23 internal, adj—of the interior of subject’s body or
3.2.9 clinical accuracy, n—ability of an infrared ear canal
body cavity, such as pulmonary artery, urinary bladder, oral,
thermometer to give a reading close to true temperature of the
rectal, etc.
site that it purports to represent.
3.2.24 laboratory error [δ], n—difference between unad-
3.2.10 clinical bias [x¯¯ ], n—mean difference between IR
d justed temperature as measured by an IR thermometer and
thermometer output and an internal body site temperature from
temperature of a blackbody, over specified operating condi-
subjects at specified conditions of ambient temperature and
tions of ambient temperature and humidity and blackbody
humidity and averaged over a selected group of subjects.
temperature ranges.
3.2.11 clinical repeatability [s ], n—pooled standard devia-
3.2.25 operating temperature, n—ambient temperature that
r
tion of changes in multiple ear canal temperature readings as
allows operation of an IR thermometer within specified labo-
taken from the same subject from the same ear with the same
ratory error range.
infrared thermometer by the same operator within a relatively
3.2.26 operating humidity, n—relative humidity of ambient
short time.
air which allows operation of an IR thermometer within a
3.2.12 combined site offset [µ ], n—calculated difference in specified laboratory error range.
s
degrees of measured temperature between a selected reference
3.2.27 oral temperature [t ], n—posterior sublingual tem-
bm
body site and ear canal temperature and averaged over the
perature as measured by a contact thermometer.
population of representative study samples.
3.2.28 physiological site offset, [µ ], n—difference in de-
p
3.2.13 contact thermometer, n—an instrument that is
grees of measured temperature between two body sites derived
adapted for measuring temperature by means of thermal
from the representative study samples.
conductivity by determining temperature at the moment when
3.2.29 probe, n—part of an IR thermometer that channels
negligible thermal energy flows between the thermometer and
net infraredradiationbetweenthe subjectandthe sensorandis
the object of measurement.
intended to be positioned near or inside the subject.
3.2.14 core temperature [t ], n—temperature at a subject’s
c 3.2.30 probe cover, n—disposable or reusable sanitary bar-
body site, such as pulmonary artery, distal esophagus, urinary
rier enveloping that part of the probe which otherwise would
bladder, or tympanic membrane, recognized as indicative of
come in contact with a subject.
internal body temperature and obtained with a contact ther-
3.2.31 professional use, n—intended or implied use of an
mometer.
instrument by individuals that are licensed or certified for
3.2.15 mode, n—an output of an IR thermometer that gives collecting information for medical diagnosing purposes.
a representation of a temperature using a disclosed calculation
3.2.32 rectal temperature [t ], n—temperature in the anal
br
technique with respect to selected reference (for example,
canal as measured by a contact thermometer.
blackbody, oral, rectal, etc.).
3.2.33 resolution, n—minimum temperature increment dis-
3.2.16 displayed temperature range, n—temperature range
played by an IR thermometer in degrees Celsius or Fahrenheit.
in degrees Celsius or Fahrenheit that can be shown by an IR
3.2.34 scale, n—graduation of temperature display in de-
thermometer.
grees Celsius or Fahrenheit.
3.2.17 IR thermometer type, n—an optoelectronic instru-
3.2.35 sensor, n—device designed to respond to net IR
ment that is capable of noncontact infrared temperature mea-
radiation and convert that response into electrical signals.
surement when placed into the auditory canal of a subject (ear
3.2.36 skin temperature, n—average temperature of a flat
canal type) or from the subject’s body surface (skin type).
skin surface as measured from the field of view of an IR skin
3.2.18 ear canal temperature [t ], n—displayed unadjusted type thermometer, with an appropriate adjustments for skin
ec
temperature measured from the field of view of an IR thermom- emissivity.
E1965−98 (2009)
3.2.37 system, n—combination of an IR thermometer and an each adjusted display mode, and for every age group of febrile
installed probe cover. and afebrile subjects on which the IR thermometer is intended
to be used.
3.2.38 subject, n—a human whose temperature is measured.
5.5.1.3 Any disclosure of clinical accuracy claims shall be
3.2.39 true temperature, n—temperature attributed to a
accompanied by disclosure of methodology and procedures.
particular site of a subject or object of measurement and
Such information shall be made available on request.
accepted as having a specified uncertainty.
5.5.1.4 Clinical accuracy should be determined in form of
3.2.40 tympanic temperature [t ], n—temperature of either
ty
two characteristics—clinical bias with stated uncertainty and
tympanic membrane as measured by a contact thermometer.
clinical repeatability, as defined in 3.2.9.
3.2.41 unadjusted mode, n—an output of IR thermometer
5.6 Ambient Conditions:
that displays temperature measured and calculated from a
5.6.1 Operating Temperature Range:
subject or object, without any corrections for variations in
5.6.1.1 The system shall meet laboratory error requirements
operating temperature, subject temperature, emissivity, etc.
as specified in 5.3 or 5.4, or both, when operating in an
4. Classification
environment from 16 to 40 °C (60.8 to 104.0 °F).
5.6.1.2 If the operating temperature range is narrower than
4.1 IR thermometers may be classified into two types: “ear
specified in 5.6.1.1, the device shall be clearly labeled with a
canal IR thermometers” and “skin IR thermometers.”
cautionary statement of the maximum or minimum operating
4.1.1 TheearcanalIRthermometerisintendedforassessing
temperatures, or both.
the internal temperature of a subject.
4.1.2 The skin IR thermometer is intended for assessing the 5.6.1.3 Under no circumstances may the upper limit of
outer surface temperature of a subject. operating temperature range be less than 35 °C (95 °F).
5.6.2 Operating Humidity Range—The relative humidity
5. Requirements
range for the operating temperature range as specified in 5.6.1
5.1 The following requirements shall apply to any IR is up to 95 %, noncondensing.
thermometer that is labeled to meet these specifications.
5.6.3 Shock:
5.6.3.1 The instrument with batteries installed (if appli-
5.2 Displayed Temperature Range:
cable)withoutacarrying(storage)casingshallwithstanddrops
5.2.1 In any display mode, an ear canal IR thermometer
withcontrolledorientationofthedevicewithoutdegradationof
shall display a subject’s temperature over a minimum range of
accuracy as specified in 5.3 or 5.4, or both, for a blackbody
34.4 to 42.2 ° C (94.0 to 108.0 °F).
temperature of or near 37 °C (98.6 °F), when tested according
5.2.2 A skin IR thermometer shall display a subject’s
to 6.3.
temperature over a minimum range of 22 to 40.0 °C (71.6 to
104.0 °F). 5.6.3.2 If an IR thermometer does not meet requirement of
5.6.3.1, a means of detecting and informing the user of its
5.3 Maximum Permissible Laboratory Error (for an Ear
inoperable state, after being subjected to shock, shall be
Canal IR Thermometer):
provided.
5.3.1 Withinthemanufacturer’sspecifiedoperatingambient
5.6.4 Storage Conditions—The instrument shall meet the
conditions (see 5.6), laboratory error δ as measured according
accuracy requirements of 5.3 or 5.4, or both, after having been
to 6.1.4 shall be no greater than values specified below:
stored or transported, or both, at any point in an environment
5.3.1.1 For blackbody temperature range from 36 to 39 °C
of – 20 to + 50 °C (– 4 to + 122 °F) and relative humidity up
(96.8 to 102.2 °F)
to 95 %, noncondensing, for a period of one month. The test
0.2 °C (0.4 °F).
procedure is specified in 6.1.6.
5.3.1.2 For blackbody temperatures less than 36 °C (96.8
5.6.5 Cleaning and Disinfection—Instrument performance
°F) or greater than 39 °C (102.2 °F)
0.3 °C (0.5 ° F). shall not be degraded by using the manufacturer’s recom-
mended procedures for cleaning and disinfection provided in
5.4 Maximum Permissible Laboratory Error (for a Skin IR
the instruction manual. Such procedures are part of the
Thermometer):
required documentation in 7.2.2.
5.4.1 Withinthemanufacturer’sspecifiedoperatingambient
5.6.6 Electromagnetic Immunity—An IR thermometer that
conditions (see 5.6)
...
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