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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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, Anesthesia Class 2 BSZ
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5730 Changer, Tube, Endotracheal Class 2 LNZ
§868.5730 Tube, Tracheal, Reprocessed Class 2 NMA
§868.5730 Airway Monitoring System Class 2 OQU
§868.5800 Tube, Tracheostomy (W/Wo Connector) Class 2 BTO
§868.5800 Tube Tracheostomy And Tube Cuff Class 2 JOH
§868.5800 Tracheotomy Care Kit Class 2 NXA
§868.5800 Cricothyrotomy Kit Class 2 OGP
§868.5800 Tracheostomy Cleaning Tray Class 2 OGV
§868.5800 Tracheostomy Kit Class 2 OGW
§868.5240 Circuit, Breathing (W Connector, Adaptor, Y Piece) Class 1 CAI
§868.5240 Anesthesia Breathing Circuit Kit (Adult & Pediatric) Class 1 OFP
§868.5250 Circulator, Breathing-Circuit Class 2 CAG
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5895 Accessory To Continuous Ventilator (Respirator) Class 2 MOD
§868.5895 Continuous, Ventilator, Home Use Class 2 NOU
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Home Use Class 2 NQY
§868.5895 Mechanical Ventilator Class 2 ONZ
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
§868.5905 Conserver, Oxygen Class 2 NFB
§868.5905 Device, Positive Pressure Breathing, Intermittent Class 2 NHJ
§868.5905 Resuscitator, Manual, Non Self-Inflating Class 2 NHK
§868.5905 Mask, Ventilator, Non-Continuous, Reprocessed Class 2 NMC
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5450 Humidifier, Respiratory, Mask (Direct Patient Interface) Class 2 OBN
§868.5450 Humidifier Nebulizer Kit Class 2 OGG
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
 Tam Cillie
 James J. Lee
 Neel Patel
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.