EN ISO 11990:2018

Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)

Publication date:   Jan 15, 2019

General information

60.60 Standard published   Oct 17, 2018

CEN

CEN/TC 123 Lasers and photonics

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment | 31.260   Optoelectronics. Laser equipment

Buying

  Published

PDF - €36.30

  English  



Buy

Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11990-1:2014

WITHDRAWN
EN ISO 11990-2:2014

NOW

PUBLISHED
EN ISO 11990:2018
60.60 Standard published
Oct 17, 2018

REVISED BY

IN_DEVELOPMENT
prEN ISO 11990 rev