| ISO 11990 Third edition 2018-08 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
| Recognition Number | Radiology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 12-323 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Radiology |
| FDA Tech | Ilko Ilev FDA/OMPT/CDRH/OSEL/DBP/ 301-796-2489 ilko.ilev@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5740 | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Class 2 | CBI |
| §868.5730 | Changer, Tube, Endotracheal | Class 2 | LNZ |
| §868.5730 | Tube, Tracheal (W/Wo Connector) | Class 2 | BTR |
| §868.5730 | Tube, Tracheal, Reprocessed | Class 2 | NMA |
| There is no relevant guidance developed at this time. |