Standard Historical Last Updated: Jul 11, 2011
ASTM E1112-00(2006)

Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

Abstract

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.

Scope

1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures.

1.2 This specification does not cover infrared thermometers. Specification E 1965 covers specifications for IR thermometers.

1.3 The values stated in SI units are to be regarded as the standard.

The following precautionary caveat pertains only to the test method portion, Section 5, 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 users of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.33
Pages: 4
DOI: 10.1520/E1112-00R06
ICS Code: 11.040.55