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  • ASTM
    E1965-98(2023) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
    Edition: 2023
    $86.11
    Unlimited Users per year

Description of ASTM-E1965 2023

ASTM E1965-98-Reapproved2023

Active Standard: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature




ASTM E1965

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.


Keywords

auditory canal; body temperature; ear; fever; infrared; medical instrument; temperature; thermometer; tympanic membrane;


ICS Code

ICS Number Code 17.040.20 (Properties of surfaces)


DOI: 10.1520/E1965-98R23

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