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ASTM E 1965 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature


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ASTM E 1965 Document Information:

Title
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

ASTM International

Publication Date:
Aug 10, 1998

Scope:

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.

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.

The specification sets limits for laboratory accuracy and requires determination and disclosure of clinical accuracy of the covered instruments.

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

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.

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 and health practices and determine the applicability of regulatory limitations prior to use.

2 Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara, CA 95050.

3 Available from Global Engineering Documents, 15 Inverness Way East, Englewood, CO 80112.

Keywords:

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

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