激光和激光相关设备. 气管轴和气管管套耐激光性的测定

[中文适用范围]： 本文件规定了一种测试气管导管轴和套囊区域（包括设计用于抵抗激光点燃的气管导管充气系统）的连续波（CW）激光耐受性的方法。 注1：在解释这些结果时，用户应注意以下事实：该测试方法的结果对临床情况的直接适用性尚未完全确定。 注 2：使用该方法测试的产品的用户应注意以下事实：激光器对波长敏感，并在其预期使用的波长下进行测试。 如果使用其他波长进行测试，请明确说明功率设置和传输模式。 注意 — 此测试方法可能涉及危险材料、操作和设备。 本文件提供了有关尽量减少与其使用相关的一些风险的建议，但并不旨在解决所有此类风险。 本文件的用户有责任建立适当的安全和健康实践，并在使用前确定监管限制的适用性。 [外文原描述]： This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist ignition by a laser. NOTE 1 When interpreting these results, the attention of the user is drawn to the fact that the direct applicability of the results of this test method to the clinical situation has not been fully established. NOTE 2 The attention of the users of products tested by this method is drawn to the fact that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, explicitly state the power settings and modes of delivery. CAUTION — This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.