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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 12-323
Standard
ISO 11990 Third edition 2018-08
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
Scope/Abstract
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.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 11990-1 Frist edition [Rec# 12-247] will be superseded by recognition of ISO 11990 Third edition [Rec# 12-323]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-247] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 12-247] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Ilko Ilev
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2489
  ilko.ilev@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Radiology
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