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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 040 Date of Entry 08/14/2015 
FR Recognition Number 1-103
ISO  5367 Fifth edition 2014-10-15
Anaesthetic and respiratory equipment - Breathing sets and connectors
ISO 5367:2014 specifies basic 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.
ISO 5367:2014 is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.
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
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 8.1 General
Clause 8.4.2 The manufacturer shall, when requested, provide information on the recommended maximum working temperature of the breathing set or breathing tube when attached to a heated humidifier.
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
§868.5160 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
 Annie Abraham
 Sidra Mirza
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.