ASTM E1112

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. 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.

2. Referenced Documents

E1104 Specification for Clinical Thermometer Probe Covers and Sheaths
E1965 Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
E344 Terminology Relating to Thermometry and Hydrometry
CFR Part 87 Establishment Registration and Premarket Notification Procedure
UL 544 Standards for Safety, Medical and Dental Equipment
UL 913 Standards for Safety, Intrinsically Safe Electrical Circuits and Equipment for Use in Hazardous Location
USP Latest Issue Biological Test

Index Terms

clinical thermometers; electronic thermometers; intermittent determination of patient temperature; ICS Number Code 11.040.55

Citing ASTM Standards

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