ASTM E1965-98

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact
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Designation: E 1965 – 98
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Specification for
Infrared Thermometers for Intermittent Determination of
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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 (e) indicates an editorial change since the last revision or reapproval.
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1. Scope ASTM Test Methods
E 344 Terminology Relating to Thermometry and Hygrom-
1.1 This specification covers electronic instruments in-
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etry
tended for intermittent measuring and monitoring of patient
E 667 Specification for Clinical Thermometers (Maximum
temperatures by means of detecting the intensity of thermal
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Self-Registering, Mercury-in-Glass)
radiation between the subject of measurement and the sensor.
E 1112 Specification for Electronic Thermometers for Inter-
1.2 The specification addresses assessing subject’s body
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mittent Determination of Patient Temperature
internal temperature through measurement of thermal emission
2.2 International Electrotechnical Commission Standards:
from the ear canal. Performance requirements for noncontact
IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1;
temperature measurement of skin are also provided.
General Requirements for Safety. Collateral Standard:
1.3 The specification sets limits for laboratory accuracy and
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Electromagnetic Compatibility—Requirements and Tests
requires determination and disclosure of clinical accuracy of
IEC 1000-4-2: 1995 Electromagnetic Compatibility
the covered instruments.
(EMC)—Part 4: Testing and Measurement Techniques;
1.4 Performance and storage limits under various environ-
Section 2: Electrostatic Discharge Immunity Test: Basic
mental conditions, requirements for labeling and test proce-
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EMC Publication (Rev. of IEC 801-2)
dures are established.
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IEC 1000-4-3: 1995 Electromagnetic Compatibility
NOTE 1—For electrical safety consult Underwriters Laboratory Stan-
2.3 Other Standards:
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dards .
International Vocabulary of Basic and General Terms in
NOTE 2—For electromagnetic emission requirements and tests refer to
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Metrology (VIM)
CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic
Disturbance Characteristics of Industrial, Scientific, and Medical (ISM)
3. Terminology
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Radiofrequency Equipment .
3.1 Definitions—The definitions given in Terminology
1.5 The values of quantities stated in SI units are to be
E 344 apply.
regarded as the standard. The values of quantities in parenthe-
3.2 Definitions of Terms Specific to This Standard—The
ses are not in SI and are optional.
terms defined below are for the purposes of this specification
1.6 The following precautionary caveat pertains only to the
only. Manufacturers should use this terminology in labeling
test method portion, Section 6, of this specification: This
instruments and in technical and sales literature.
standard does not purport to address all of the safety concerns,
3.2.1 accuracy, n—ability of an infrared thermometer to
if any, associated with its use. It is the responsibility of the user
give a reading close to the true temperature.
of this standard to establish appropriate safety and health
3.2.2 adjusted mode, n—output of an IR thermometer that
practices and determine the applicability of regulatory limita-
gives temperature measured and calculated from a subject or
tions prior to use.
object, by correcting such temperature for variations in ambi-
ent temperature, subject’s temperature, emissivity, body site
2. Referenced Documents
(that is, oral,or rectal), etc.
2.1 ASTM Standards:
3.2.3 axillary temperature [t ], n—temperature at the apex
ba
E 177 Practice for Use of the Terms Precision and Bias in
of either axilla (armpit) as measured by a contact thermometer.
3.2.4 blackbody, n—a reference source of infrared radiation
made in the shape of a cavity and characterized by precisely
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known temperature of the cavity walls and having effective
This specification is under the jurisdiction of ASTM Committee E-20 on
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
emissivity at the cavity opening arbitrarily considered equal to
on Medical Thermometry.
unity.
Current edition approved Aug. 10, 1998. Published October 1998.
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Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara,
CA 92050.
3 4
Available from Global Engineering Documents. 3130 South Harbor Blvd., Ste. Annual Book of ASTM Standards, Vol 14.02.
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330, Santa Ana, CA 92704. Annual Book of ASTM Standards, Vol 14.03.
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