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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 061 Date of Entry 12/18/2023 
FR Recognition Number 1-164
Standard
ISO  5361 Fourth edition 2023-01
Anaesthetic and respiratory equipment - Tracheal tubes and connectors
Scope/Abstract
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.

Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.

Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.

NOTE 1 There is guidance or rationale for this clause contained in Annex A.2.

NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
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FDA recognition of ISO 5361 Third edition 2016-09 [Rec# 1-118] will be superseded by recognition of ISO 5361 Fourth edition 2023-11 [Rec# 1-164]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-118] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-118] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
Relevant FDA Guidance and/or Supportive Publications*
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, issued March 2015.

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 Contacts
 Neel Patel
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6274
  Neel.Patel@fda.hhs.gov
 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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