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EVS-EN ISO 11990:2018

Laserid ja laseritega seotud varustus. Traheaaltorude šaftide ja trahhea-mansettide laserikindluse määramine

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Kehtiv alates 02.11.2018
Alusdokumendid
ISO 11990:2018; EN ISO 11990:2018
Direktiivid või määrused
93/42/EEC Meditsiinivahendid

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
02.11.2018
Põhitekst
09.12.2014
Põhitekst
09.12.2014
Põhitekst
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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