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.
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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.
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.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E344 Terminology Relating to Thermometry and Hydrometry
E667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
E1112 Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
International Electrotechnical Commission Standards
IEC1000-4-3: 1995 Electromagnetic Compatibility
auditory canal; body temperature; ear; fever; infrared; medical instrument; temperature; thermometer; tympanic membrane; Auditory canal; Body temperature; Ear; Infrared thermometers; Laboratory apparatus--specifications; Patient care instruments (specifications); Thermometers--specifications; Tympanic membrane;
ICS Number Code 17.040.20 (Properties of surfaces)
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