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Standard Specification for Clinical Thermometer Probe Covers and Sheaths
NORMA vydaná dňa 1.2.2023
Označenie normy: ASTM E1104-98(2023)
Dátum vydania normy: 1.2.2023
Kód tovaru: NS-1102537
Počet strán: 3
Približná hmotnosť: 9 g (0.02 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
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.
Keywords:
clinical, probe covers, sheaths, thermometer,, ICS Number Code 11.040.99 (Other medical equipment),17.200.20 (Temperature-measuring instruments)
1. 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 manufacturers 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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2. Referenced Documents | ||||||
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