ASTM E1104-98(2023) PDF

Scope: 1.1 This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used within the standards are provided. 1.2 The requirements contained herein are intended to ensure adequate isolation of the patient from the temperaturemeasuring device. In addition, the safety and health of the patient shall not be adversely affected. When used in accordance with the manufacturer’s instructions, the probe cover, sheath, and temperature-measuring device shall remit correct temperature readings as required in Specifications E667 and E1112. 1.3 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.

ASTM E1104-98(2023) Referenced Document

ASTM E1112 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
ASTM E344 Terminology Relating to Thermometry and Hydrometry*， 2023-12-01 Update
ASTM E667 Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

2023 ASTM E1104-98(2023) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
2016 ASTM E1104-98(2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
1998 ASTM E1104-98(2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
1998 ASTM E1104-98(2003) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
1998 ASTM E1104-98 Standard Specification for Clinical Thermometers Probe Covers and Sheaths