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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 062 Date of Entry 05/29/2024 
FR Recognition Number 1-171
Standard
ISO  5367 Sixth edition 2023-07
Anaesthetic and respiratory equipment - Breathing sets and connectors
Scope/Abstract
This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions.

This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.

Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
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FDA recognition of ISO 5367 Fifth edition 2014-10-15 [Rec# 1-103] will be superseded by recognition of ISO 5367 Sixth edition 2023-07 [Rec# 1-171]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-103] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 1-103] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5160 Gas machine for anesthesia or analgesia.
§868.5240 Anesthesia breathing circuit.
§868.5250 Breathing circuit circulator.
§868.5450 Respiratory gas humidifier.
§868.5730 Tracheal tube.
§868.5800 Tracheostomy tube and tube cuff.
§868.5895 Continuous ventilator.
§868.5905 Noncontinuous ventilator (IPPB).
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.

Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II, issued February 1989.

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
 Sidra Mirza
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6471
  sidra.mirza@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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