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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

Status
Published
Publication Date
31-Jan-2023
ICS
17.040.20 - Properties of surfaces
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.33 - Medical/Surgical Instruments
Current Stage
Ref Project

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ASTM E1965-98(2023) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient TemperatureASTM E1965-98(2023) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
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ASTM E1965-98(2023) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
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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
1
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
4
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-
5
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-
2
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)
3
3
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.
3
EMC Publication (Rev. of IEC 801-2)
3
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
3
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
4
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
2
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
1

---------------------- Page: 1 ----------------------
E1965 − 98 (2023)
3.2.1 The t
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1.1 This test method covers a single laboratory procedure that can be used to develop data from which either the relative abrasivity of any slurry (Miller Number) or the response of different materials to the abrasivity of different slurries (SAR Number), can be determined.  
1.2 The test data obtained by this procedure is used to calculate either a number related to the rate of mass loss of duplicate standard-shaped 27 % chromium iron wear blocks when run for a period of time in the slurry of interest (Miller Number), or to calculate a number related to the rate of mass loss (converted to volume loss) of duplicate standard-shaped wear specimens of any material of interest when run for a period of time in any slurry of interest (SAR Number).  
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Standard Test Method for Measuring Abrasion Using the Dry Sand/Rubber Wheel Apparatus

SIGNIFICANCE AND USE
5.1 The severity of abrasive wear in any system will depend upon the abrasive particle size, shape, and hardness, the magnitude of the stress imposed by the particle, and the frequency of contact of the abrasive particle. In this practice these conditions are standardized to develop a uniform condition of wear which has been referred to as scratching abrasion (1 and 3). The value of the practice lies in predicting the relative ranking of various materials of construction in an abrasive environment. Since the practice does not attempt to duplicate all of the process conditions (abrasive size, shape, pressure, impact, or corrosive elements), it should not be used to predict the exact resistance of a given material in a specific environment. Its value lies in predicting the ranking of materials in a similar relative order of merit as would occur in an abrasive environment. Volume loss data obtained from test materials whose lives are unknown in a specific abrasive environment may, however, be compared with test data obtained from a material whose life is known in the same environment. The comparison will provide a general indication of the worth of the unknown materials if abrasion is the predominant factor causing deterioration of the materials.
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1.1 This test method covers laboratory procedures for determining the resistance of metallic materials to scratching abrasion by means of the dry sand/rubber wheel test. It is the intent of this test method to produce data that will reproducibly rank materials in their resistance to scratching abrasion under a specified set of conditions.  
1.2 Abrasion test results are reported as volume loss in cubic millimetres for the particular test procedure specified. Materials of higher abrasion resistance will have a lower volume loss.  
Note 1: In order to attain uniformity among laboratories, it is the intent of this test method to require that volume loss due to abrasion be reported only in the metric system as cubic millimetres. 1 mm3 = 6.102 × 10−5 in.3.  
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1.3.5 Procedure E—A short-term variation of Procedure B that is useful in the ranking of materials with medium- or low-abrasion resistance.  
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4.3 This test method is for the measurement of the thickness of the coating over a very small area and not of the average or minimum thickness per se.  
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4.5 The coating thickness is an important factor in the performance of a coating in service.
SCOPE
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1.1 This practice is intended to provide a basis for simulating radioactive contamination consistent with processes used to evaluate decontamination. The methods described provide a “loose-type” radiological or surrogate contamination on nonporous surfaces; these methods provide a surface contamination that may be easily removed by brushing or flushing with water.  
1.2 This practice is intended for nonporous surfaces such as stainless steel, aluminum, glass, laminates, and epoxy painted surfaces. Preparation of porous substrates is not addressed, although similar methodologies may be used. A different practice is employed using Practice E3190, to produce “fixed” contamination.  
1.3 The chemical simulants shall not include nor generate toxic byproducts as defined by U.S. Occupational Safety and Health Administration (OSHA) during preparation, application, or removal under normal conditions. A Safety Data Sheet (SDS) shall be provided so that appropriate personal protective equipment (PPE) can be selected.  
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
1.5 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.  
1.6 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.

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