ISO 11990 Lasers and Laser-Related Equipment - Determination of Laser Resistance of Tracheal Tube Shaft and Tracheal Tube Cuffs

ISO 11990 Lasers and Laser-Related Equipment - Determination of Laser Resistance of Tracheal Tube Shaft and Tracheal Tube Cuffs

In the standard “ISO 11990 Lasers and laser-related equipment – ​​Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs” developed by the International Organization for Standardization (ISO), it is stated that the shaft of a tracheal tube and the cuff areas, including the inflation system, of tracheal tubes designed to resist ignition by a laser are continuously A method for testing wave laser resistance is described.

ISO 11990 Lasers and Laser-Related Equipment - Determination of Laser Resistance of Tracheal Tube Shaft and Tracheal Tube Cuffs

However, it is a fact that when interpreting these results, the direct applicability of the results of this test method to the clinical situation has not been fully determined. The attention of users of products tested by this method is drawn to the fact that the laser will be wavelength sensitive and will be tested at the wavelength for which it is intended to be used. If tested using other wavelengths, power settings and distribution modes should be clearly stated.

This testing method may involve hazardous materials, processes, and equipment. This standard provides recommendations for minimizing some of the risks associated with its use, but does not purport to address all such risks. It is the responsibility of those using this standard to establish appropriate safety and health practices and to determine the applicability of legal limitations prior to use.

The main components of the tracheostomy tube are universal in various designs. The tube shaft is arc-shaped and designed as a single cannula or double cannula (inner and outer) tracheostomy tube. It may have a cuff that provides an airtight seal to facilitate positive pressure ventilation and reduce the risk of aspiration. Supplied with an obturator for ease of insertion. The neck flange helps secure the tracheostomy tube to the neck skin and stabilize its position.

Short-term tracheostomy tubes have a 15 mm connector that allows connection to airway equipment. Long-term tracheostomy tubes may have a low-profile flange that is more inconspicuous but cannot be connected to airway equipment.

The length and diameter of the trachea are roughly proportional to the size of the individual. The tracheostomy tube should be selected based on the tube's outer diameter, inner diameter, and length rather than the manufacturer's size, which are not standardized across models or manufacturers.

In its simplest form, an endotracheal tube is a tube made of polyvinyl chloride that is placed between the vocal cords through the trachea. It provides oxygen and inhaled gases to the lungs and protects them from contaminations such as stomach contents or blood.

The laser-resistant endotracheal tube is a silicone endotracheal tube with a laser-resistant aluminum coating and a silicone outer sheath. The visible aluminum coating is laser resistant according to standards.

For the purposes of this standard,

  • Beam diameter refers to the smallest diameter of the circular aperture in a plane perpendicular to the beam axis containing 95 percent of the total beam power (energy)
  • Beam cross-sectional area refers to the smallest completely filled area containing 95 percent of the total beam power (energy).
  • Combustion is any ongoing combustion process occurring within or on the sample caused by the chemical oxidation process that occurs with the release of heat.
  • The cuff is an inflatable balloon that is permanently fitted around the tracheal tube near the patient's end to provide an effective seal between the tube and the trachea.
  • Harm is any change other than inflammation that may affect patient safety or the effectiveness of the tracheal tube due to increased risk of ignition.
  • Flammable means capable of being ignited and subjected to flaming combustion.
  • Ignition is the occurrence of combustion caused by power distribution.
  • Laser resistance refers to the measure of a material's ability to withstand laser power without ignition or damage.
  • Melting behavior is the softening of a material under the influence of heat (shrinking, dripping and burning of the molten material).
  • Penetration resistance is the ability of a material to prevent the passage of laser energy.
  • The shaft is the part of the tracheal tube between the cuff and the machine end of the tube.

The test method described can cause a rocket-like fire involving the tracheal tube. Such a fire can produce intense heat, light and toxic gases. To simulate worst-case conditions, the material is principally exposed to laser power of known characteristics in an environment containing up to 98 percent plus/minus 2 percent oxygen.

Among the numerous tests, measurements, analysis and evaluation studies carried out for businesses in various sectors, our organization, with its trained and expert staff and advanced technological equipment, complies with the "ISO 11990 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs" standard. It also provides defined testing services.

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