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.
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 manufacturers instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E 667 and E 1112.
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