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The Development and Evaluation of Tests for Safety and Efficacy of Cuffed Tracheal Tubes

机译:袖套气管导管安全性和有效性试验的开发与评价

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This report represents the results of a study involving the development and evaluation of tests for determining the safety and performance of cuffed tracheal tubes. Included in this document are (1) a detailed statement of the scope and significance of the potential hazards associated with the use of these devices (2) an evaluation of the feasibility, practicality and validity of testing procedures including a test for the evaluation of tracheal injury, and (3) a review of the existing tracheal tube standards (ANSI Z-79.1-1974 and ANSI Z-79.5-1974).

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