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.
ASTM E1104-98(2016) Referenced Document
ASTM E1112 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature*, 2018-10-01 Update
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*, 2017-12-15 Update
ASTM E1104-98(2016) history
2023ASTM E1104-98(2023) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
2016ASTM E1104-98(2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
1998ASTM E1104-98(2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
1998ASTM E1104-98(2003) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
1998ASTM E1104-98 Standard Specification for Clinical Thermometers Probe Covers and Sheaths