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ASTM E1965-98(2023)

Current Reaffirmation

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

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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.


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.


SDO ASTM: ASTM International
Document Number E1965
Publication Date Feb. 1, 2023
Language en - English
Page Count 17
Revision Level 98(2023)
Supercedes
Committee F04.33
Publish Date Document Id Type View
Aug. 10, 1998 E1965-98 Revision
Feb. 1, 2023 E1965-98R23 Reaffirmation
Oct. 1, 2016 E1965-98R16 Reaffirmation
May 1, 2009 E1965-98R09 Reaffirmation
May 10, 2003 E1965-98R03 Reaffirmation