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This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. The temperature range of the instrument shall display temperature within the specific range requirement and regards to its accuracy, no individual reading shall be in error by more than the values that are determined. The operating environment must meet the determined accuracy requirements when operated in an environment of a certain temperature and also with a certain relative humidity. The resolutions of analog display such as Celsius graduations, Fahrenheit graduations, scale graduation marks and pointer width shall also be observed. Its digital display shall conform to the standard resolution, readability and buttery condition of the material. The case material of the instrument and non disposable accessories shall withstand biological and physical cleaning without performance degradation. It shall also withstand dropping without presenting an electrical safety hazard. Those parts of the electronic thermometer system intended for contact with anatomical sites for the purpose of temperature measurement as specified by the manufacturer shall be also be nontoxic. The following tests shall be conducted in order to determine the instrument's performance: cleaning test, toxicity test, and accuracy test.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures.
1.2 This specification does not cover infrared thermometers. Specification covers specifications for IR thermometers.
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.4 The following precautionary caveat pertains only to the test method portion, Section 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. , of this specification.
1.5 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E344 Terminology Relating to Thermometry and Hydrometry
E1104 Specification for Clinical Thermometer Probe Covers and Sheaths
E1965 Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Underwriters Laboratory StandardsUL 544 Standards for Safety, Medical and Dental Equipment UL 913
U.S. PharmacopeiaUSP Latest Issue Biological Test
Federal RegulationsCFR Part 87 Establishment Registration and Premarket Notification Procedure
ICS Number Code 11.040.55 (Diagnostic equipment)
UNSPSC Code 42182201(Electronic medical thermometers)
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ASTM E1112-00(2018), Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top