This part of ISO 11990 specifies a method for testing the continuous wave (cw) laser resistance of the cuff area of a tracheal tube designed to withstand inflammation from a laser. Other components of the system, such as the inflation system and the shaft (as specified in ISO11990-1), are outside the scope of this part of ISO 11990. NOTE 1 The procedure for testing the laser resistance of the tracheal tube shaft is within the scope of ISO 11990-1. The established test method can be used to describe the properties of materials, products or assembly units in response to exposure to heat and flame under controlled laboratory conditions. It does not describe or assess the fire hazard or risk of fire of materials, products and assemblies in real clinical use conditions. However, the results of this test may be taken into account as part of a fire risk assessment that takes into account all the factors involved in determining the risk of a particular end use. NOTE 2 These results should be interpreted with caution because the direct transferability of results from this test procedure to the clinical situation is not always given. NOTE 3 This test procedure may involve the use of hazardous materials, handling and equipment. This part of ISO 11990 provides guidance on how to minimize risks but does not purport to address all safety issues arising from its application. It is the responsibility of the user of this test method to determine the appropriate practical health and safety measures and to determine the applicability of regulatory restrictions.
EN ISO 11990-2:2014 Referenced Document
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 11145:2006 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 11990-1:2011 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft
ISO 14408:2005 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
ISO 5361:2012 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
EN ISO 11990-2:2014 history
2014EN ISO 11990-2:2014 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs
2010EN ISO 11990-2:2010 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs