DIN EN ISO 11990:2018
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018); German version EN ISO 11990:2018

Standard No.

DIN EN ISO 11990:2018

Release Date

2018

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 11990:2018-12

Latest

DIN EN ISO 11990:2018-12

Replace

DIN EN ISO 11990:2017 DIN EN ISO 11990-1:2016 DIN EN ISO 11990-2:2016

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.

DIN EN ISO 11990:2018 Referenced Document

• DIN EN 60601-2-22:2015 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2007 + A1:2012); German version EN 60601-2-22:2013
• DIN EN 60825-1:2015 Safety of laser products - Part 1: Equipment classification and requirements (IEC 60825-1:2014); German version EN 60825-1:2014
• DIN EN ISO 11145:2016 Optics and photonics - Lasers and laser-related equipment - Vocabulary and symbols (ISO 11145:2016); German version EN ISO 11145:2016
• DIN EN ISO 11146-1:2005 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams (ISO 11146-1:2005); German version EN ISO 11146-1:2005
• DIN EN ISO 11810:2016 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
• DIN EN ISO 14408:2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016); German version EN ISO 14408:2016
• DIN EN ISO 5361:2017 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016); German version EN ISO 5361:2016
• IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
• ISO 11145:2016 Optics and photonics - Lasers and laser-related equipment - Vocabulary and symbols
• ISO 11146-1:2005 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
• ISO 11810:2015 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition
• ISO 14408:2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
• ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
• ISO/IEC GUIDE 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
• ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway

DIN EN ISO 11990:2018 history

• 2018 DIN EN ISO 11990:2018-12 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018); German version EN ISO 11990:2018
• 2018 DIN EN ISO 11990:2018 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018); German version EN ISO 11990:2018
• 1970 DIN EN ISO 11990 E:2017-05 Determination of laser resistance of tracheal shafts and tracheal cuffs of lasers and laser-related equipment (draft)
• 2017 DIN EN ISO 11990 E:2017 Draft Document - Lasers and laser-related Equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO/DIS 11990:2017); German and English version prEN ISO 11990:2017
• 2016 DIN EN ISO 11990-2:2016 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010); German version EN ISO 11990-2:2014
• 2011 DIN EN ISO 11990-1:2011 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011); German version EN ISO 11990-1:2011
• 2010 DIN EN ISO 11990-2:2010 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010); German version EN ISO 11990-2:2010
• 0000 DIN EN ISO 11990:2003