ASTM E1112-00(2018) - 1.10.2018
 
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 E1965 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 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 user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

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

USP

Latest Issue Biological Test

UL 913

Standards for Safety, Intrinsically Safe Electrical Circuits and Equipment for Use in Hazardous Location

E1965-98(2023)

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

E1104-98(2023)

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

E344-26a

Terminology Relating to Thermometry and Hydrometry (Includes all amendments and changes 4/21/2026).

CFR Part 87

Establishment Registration and Premarket Notification Procedure