ISO 11990:2018 光学和光学仪器-激光和激光相关设备-激光导管耐光性测定.

标准编号：ISO 11990:2018

中文名称：光学和光学仪器-激光和激光相关设备-激光导管耐光性测定.

英文名称：Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs

发布日期：2018-08

标准范围

本文件规定了一种测试气管管轴和袖带区域（包括设计用于抵抗激光点火的气管管充气系统）连续波（cw）激光阻力的方法。注1:在解释这些结果时，用户应注意，本试验方法的结果对临床情况的直接适用性尚未完全确定。注2:通过本方法测试的产品的用户应注意，激光器将对波长敏感，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，请明确说明电源设置和传输模式。警告-本试验方法可能涉及危险材料、操作和设备。本文件提供了关于尽量减少与其使用相关的一些风险的建议，但无意解决所有此类风险。本文件的使用者有责任在使用前建立适当的安全和健康实践，并确定监管限制的适用性。

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.

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