ASTM E1965-98(2016)
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
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STANDARD published on 1.10.2016
The information about the standard:
Designation standards: ASTM E1965-98(2016)
Publication date standards: 1.10.2016
SKU: NS-667185
The number of pages: 18
Approximate weight : 54 g (0.12 lbs)
Country: American technical standard
Category: Technical standards ASTM
The category - similar standards:
Annotation of standard text ASTM E1965-98(2016) :
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 subjects 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.
Keywords:
auditory canal, body temperature, ear, fever, infrared, medical instrument, temperature, thermometer, tympanic membrane,, ICS Number Code 17.040.20 (Properties of surfaces)
Additional information
| 1. Scope | ||||||||||||||||
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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.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:
IEC 1000-4-2: 1995 Electromagnetic Compatibility
(EMC)Part 4: Testing and Measurement Techniques; Section 2:
Electrostatic Discharge Immunity Test: Basic EMC Publication (Rev.
of IEC 801-2) Practice for Use of the Terms Precision
and Bias in ASTM Test Methods International Vocabulary of Basic and
General Terms in Metrology (VIM) IEC 1000-4-3: 1995 Electromagnetic Compatibility 1993 Medical Electrical Equipment, Part
1; General Requirements for Safety. Collateral Standard:
Electromagnetic CompatibilityRequirements and Tests Specification for Electronic Thermometer
for Intermittent Determination of Patient Temperature Terminology Relating to Thermometry and
Hydrometry Specification for Mercury-in-Glass,
Maximum Self-Registering Clinical Thermometers |
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