Standard Active Last Updated: Feb 16, 2023 Track Document
ASTM E1104-98(2023)

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

Standard Specification for Clinical Thermometer Probe Covers and Sheaths E1104-98R23 ASTM|E1104-98R23|en-US Standard Specification for Clinical Thermometer Probe Covers and Sheaths Standard new BOS Vol. 13.01 Committee F04
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Abstract

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 are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.

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 temperature-measuring 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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.33
Pages: 3
DOI: 10.1520/E1104-98R23
ICS Code: 11.040.99; 17.200.20