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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 1-150
Standard
ISO  8836 Fifth edition 2019-12
Suction catheters for use in the respiratory tract
Scope/Abstract
This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
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
§868.6810 Catheters, Suction, Tracheobronchial Class 1 BSY
§868.6810 Airway Suction Kit Class 1 OFO
§868.6810 Tracheobronchial Suction Catheter Kit Class 1 OFR
§868.6810 Tracheal Suction Set Class 1 OFS
§868.6810 Non-Bronchoscopic Bronchoalveolar Lavage Catheter Class 1 OYI
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Annie Abraham
  FDA/OMPT/CDRH/OPEQ/OHTI/DHTIC
  240-402-5219
  Annie.Abraham@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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