DANSK DSF/FPREN ISO 11990 PDF

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 – Caution should be taken in 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 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.