ASTM E1965-98(2023)
(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.2
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.3
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 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: E1965 − 98 (Reapproved 2023)
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 1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This specification covers electronic instruments in-
ization established in the Decision on Principles for the
tended for intermittent measuring and monitoring of patient
Development of International Standards, Guides and Recom-
temperatures by means of detecting the intensity of thermal
mendations issued by the World Trade Organization Technical
radiation between the subject of measurement and the sensor.
Barriers to Trade (TBT) Committee.
1.2 The specification addresses assessing subject’s body
internal temperature through measurement of thermal emission
2. Referenced Documents
from the ear canal. Performance requirements for noncontact
2.1 ASTM Standards:
temperature measurement of skin are also provided.
E177 Practice for Use of the Terms Precision and Bias in
1.3 The specification sets limits for laboratory accuracy and
ASTM Test Methods
requires determination and disclosure of clinical accuracy of
E344 Terminology Relating to Thermometry and Hydrom-
the covered instruments.
etry
E667 Specification for Mercury-in-Glass, Maximum Self-
1.4 Performance and storage limits under various environ-
Registering Clinical Thermometers (Withdrawn 2022)
mental conditions, requirements for labeling, and test proce-
E1112 Specification for Electronic Thermometer for Inter-
dures are established.
mittent Determination of Patient Temperature
NOTE 1—For electrical safety, consult Underwriters Laboratory Stan-
dards.
2.2 International Electrotechnical Commission Standards:
NOTE 2—For electromagnetic emission requirements and tests, refer to
IEC 601-1-2:1993 Medical Electrical Equipment, Part 1;
CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic
General Requirements for Safety. Collateral Standard:
Disturbance Characteristics of Industrial, Scientific, and Medical (ISM)
Electromagnetic Compatibility—Requirements and Tests
Radiofrequency Equipment.
IEC 1000-4-2:1995 Electromagnetic Compatibility
1.5 The values of quantities stated in SI units are to be
(EMC)—Part 4: Testing and Measurement Techniques;
regarded as the standard. The values of quantities in parenthe-
Section 2: Electrostatic Discharge Immunity Test: Basic
ses are not in SI and are optional.
EMC Publication (Rev. of IEC 801-2)
1.6 The following precautionary caveat pertains only to the
IEC 1000-4-3:1995 Electromagnetic Compatibility
test method portion, Section 6, of this specification: This
2.3 Other Standards:
standard does not purport to address all of the safety concerns,
International Vocabulary of Basic and General Terms in
if any, associated with its use. It is the responsibility of the user
Metrology (VIM)
of this standard to establish appropriate safety, health, and
environmental practices and determine the applicability of
3. Terminology
regulatory limitations prior to use.
3.1 Definitions—The definitions given in Terminology E344
apply.
1 3.2 Definitions of Terms Specific to This Standard:
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 Feb. 1, 2023. Published February 2023. Originally
approved in 1998. Last previous edition approved in 2016 as E1965 – 98 (2016). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/E1965-98R23. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Available from Underwriters Laboratories (UL), 2600 N.W. Lake Rd., Camas, Standards volume information, refer to the standard’s Document Summary page on
WA 98607-8542, http://www.ul.com. the ASTM website.
3 5
Available from Global Engineering Documents, 15 Inverness Way East, The last approved version of this historical standard is referenced on www.ast-
Englewood, CO 80112. m.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1965 − 98 (2023)
3.2.1 The terms defined below are for the purposes of this 3.2.16 displayed temperature range, n—temperature range
specification only. Manufacturers should use this terminology in degrees Celsius or Fahrenheit that can be shown by an IR
in labeling instruments and in technical and sales literature. thermometer.
3.2.2 accuracy, n—ability of an infrared thermometer to
3.2.17 IR thermometer type, n—an optoelectronic instru-
give a reading close to the true temperature.
ment that is capable of noncontact infrared temperature mea-
3.2.3 adjusted mode, n—output of an IR thermometer that surement when placed into the auditory canal of a subject (ear
gives the temperature measured and calculated from a subject canal type) or from the subject’s body surface (skin type).
or object, by correcting such temperature for variations in
3.2.18 ear canal temperature [t ], n—displayed unadjusted
ec
ambient temperature, the subject’s temperature, emissivity,
temperature measured from the field of view of an IR thermom-
body site (that is, oral, or rectal), etc.
eter whose probe is placed into the auditory canal of a subject
3.2.4 axillary temperature [t ], n—temperature at the apex according to the manufacturer’s recommendations.
ba
of either axilla (armpit) as measured by a contact thermometer.
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
3.2.20 infrared (IR), adj—of the electromagnetic radiation
known temperature of the cavity walls and having effective
within the mid- and far infrared spectral ranges (approximately
emissivity at the cavity opening arbitrarily considered equal to
from 3 to 30 μm wavelength).
unity.
3.2.21 infrared (IR) thermometer, n—optoelectronic instru-
3.2.6 blackbody temperature [t ], n—temperature of
BB
ment adapted for noncontact measurement of the temperature
blackbody cavity walls as measured by an imbedded or
of a subject by utilizing infrared radiation exchange between
immersed contact thermometer.
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-
d
the urinary bladder as measured by a contact thermometer.
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 justed temperature as measured by an IR thermometer and
d
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 infrared radiation between the subject and the sensor and is
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 the pulmonary artery, distal esophagus,
rier enveloping that part of the probe which otherwise would
urinary bladder, or tympanic membrane, recognized as indica-
come in contact with a subject.
tive of internal body temperature and obtained with a contact
thermometer. 3.2.31 professional use, n—intended or implied use of an
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
technique with respect to selected reference (for example, 3.2.32 rectal temperature [t ], n—temperature in the anal
br
blackbody, oral, rectal, etc.). canal as measured by a contact thermometer.
E1965 − 98 (2023)
3.2.33 resolution, n—minimum temperature increment dis- 5.4.1 Within the manufacturer’s specified operating ambient
played by an IR thermometer in degrees Celsius or Fahrenheit. conditions (see 5.6) over the display temperature range as
specified in 5.2.2, laboratory error δ as measured according to
3.2.34 scale, n—graduation of temperature display in de-
6.1.5 shall be no greater than 0.3 °C (0.5 °F).
grees Celsius or Fahrenheit.
5.5 Special Requirements:
3.2.35 sensor, n—device designed to respond to net IR
5.5.1 Clinical Accuracy:
radiation and convert that response into electrical signals.
5.5.1.1 The clinical accuracy requirement is applicable only
3.2.36 skin temperature, n—average temperature of a flat
to an ear canal IR thermometer system and the corresponding
skin surface as measured from the field of view of an IR skin
age groups of subjects for which such a thermometer is labeled
type thermometer, with an appropriate adjustment for skin
or implied to be used.
emissivity.
5.5.1.2 Clinical accuracy shall be determined separately for
3.2.37 system, n—combination of an IR thermometer and an
each of the following conditions: for each device model, for
installed probe cover.
each adjusted display mode, and for every age group of febrile
3.2.38 subject, n—a human whose temperature is measured.
and afebrile subjects on which the IR thermometer is intended
to be used.
3.2.39 true temperature, n—temperature attributed to a
5.5.1.3 Any disclosure of clinical accuracy claims shall be
particular site of a subject or object of measurement and
accompanied by disclosure of methodology and procedures.
accepted as having a specified uncertainty.
Such information shall be made available on request.
3.2.40 tympanic temperature [t ], n—temperature of either
ty
5.5.1.4 Clinical accuracy should be determined in the form
tympanic membrane as measured by a contact thermometer.
of two characteristics—clinical bias with stated uncertainty and
3.2.41 unadjusted mode, n—an output of IR thermometer
clinical repeatability, as defined in 3.2.9.
that displays temperature measured and calculated from a
5.6 Ambient Conditions:
subject or object, without any corrections for variations in
5.6.1 Operating Temperature Range:
operating temperature, subject temperature, emissivity, etc.
5.6.1.1 The system shall meet laboratory error requirements
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).
4.1 IR thermometers may be classified into two types: “ear
5.6.1.2 If the operating temperature range is narrower than
canal IR thermometers” and “skin IR thermometers.”
specified in 5.6.1.1, the device shall be clearly labeled with a
4.1.1 The ear canal IR thermometer is intended for assessing
cautionary statement of the maximum or minimum operating
the internal temperature of a subject.
temperatures, or both.
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) without a carrying (storage) casing shall withstand drops
5.2.1 In any display mode, an ear canal IR thermometer
with controlled orientation of the device without degradation of
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
5.6.3.2 If an IR thermometer does not meet the requirement
104.0 °F).
of 5.6.3.1, a means of detecting and informing the user of its
...
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