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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 028 Date of Entry 03/16/2012 
FR Recognition Number 1-62
ISO  5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
Identical Adoption
ANSI AAMI ISO 5356-1:2004
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
ISO 5356-1:2004 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic-gas scavenging systems and vaporizers.
ISO 5356-1:2004 gives requirements for the following conical connectors:
-8,5 mm sizes intended for use in paediatric breathing systems;
-15 mm and 22 mm sizes intended for general use in breathing systems;
-22 mm latching connectors (including performance requirements);
-23 mm size intended for use with vaporizers, but not for use in breathing systems;
-30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system.
ISO 5356-1:2004 does not specify the medical devices and accessories on which these connections are to be provided.
Requirements for the application of conical connectors are not included in ISO 5356-1:2004, but are or will be given in the relevant International Standards for specific medical devices and accessories.
NOTE Requirements for screw-threaded weight-bearing conical connectors are specified in ISO 5356-2.
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
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5240 Circuit, Breathing (W Connector, Adaptor, Y Piece) Class 1 CAI
§868.5260 Filter, Bacterial, Breathing-Circuit Class 2 CAH
§868.5375 Condenser, Heat And Moisture (Artificial Nose) Class 1 BYD
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5720 Tube, Bronchial (W/Wo Connector) Class 2 BTS
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5740 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class 2 CBI
§868.5800 Tube, Tracheostomy (W/Wo Connector) Class 2 BTO
§868.5800 Tube Tracheostomy And Tube Cuff Class 2 JOH
§868.5810 Connector, Airway (Extension) Class 1 BZA
§868.5870 Valve, Non-Rebreathing Class 2 CBP
§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
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
§868.5965 Attachment, Breathing, Positive End Expiratory Pressure Class 2 BYE
§868.5975 Set, Tubing And Support, Ventilator (W Harness) Class 1 BZO
Relevant FDA Guidance and/or Supportive Publications*
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 Contact
 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.