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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 1-127
Standard
ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
Scope/Abstract
ISO 16628:2008 provides requirements for designation and labelling of tracheobronchial tubes, including colour coding of the bronchial cuff and its associated pilot balloon. Tracheobronchial tubes that include bronchus blockers are excluded from the scope of ISO 16628:2008.
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.
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
FDA Technical Contacts
 Deepika Lakhani
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  301-796-4042
  Deepika.Lakhani@fda.hhs.gov
 William C. Maloney
  FDA/OC/CDRH/OPEQ/ORP/DRPIII/
  301-796-6272
  William.Maloney@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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