ISO 22248:2020 激光和激光相关设备 激光诱导损伤阈值的试验方法 医用光束传送系统的分类

标准编号：ISO 22248:2020

中文名称：激光和激光相关设备 激光诱导损伤阈值的试验方法 医用光束传送系统的分类

英文名称：Lasers and laser-related equipment — Test methods for laser-induced damage threshold — Classification of medical beam delivery systems

发布日期：2020-11

标准范围

本文件规定了一种测试医疗光束传输系统激光诱导点火和损坏的方法，以便根据分类系统检查合适的产品。注1:由于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，因此在解释这些结果时要小心。注2:使用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，则需要明确说明功率设置和光束传输模式。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 laser-induced ignition and damage of medical beam delivery systems to allow checking of suitable products according to the classification system.NOTE 1 Take care when interpreting these results, since the direct applicability of the results of this test method to the clinical situation has not been fully established.NOTE 2 Users of products tested by this method are cautioned 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, the power settings and modes of beam delivery need to be explicitly stated.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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