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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 028 FR Publication Date 03/16/2012 
FR Recognition Number 1-62
Standard
ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.5975 Set, Tubing And Support, Ventilator (W Harness) Class 1 BZO
§868.5965 Attachment, Breathing, Positive End Expiratory Pressure Class 2 BYE
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§868.5870 Valve, Non-Rebreathing Class 2 CBP
§868.5810 Connector, Airway (Extension) Class 1 BZA
§868.5800 Tube Tracheostomy And Tube Cuff Class 2 JOH
§868.5800 Tube, Tracheostomy (W/Wo Connector) Class 2 BTO
§868.5740 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class 2 CBI
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5720 Tube, Bronchial (W/Wo Connector) Class 2 BTS
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5375 Condenser, Heat And Moisture (Artificial Nose) Class 1 BYD
§868.5260 Filter, Bacterial, Breathing-Circuit Class 2 CAH
§868.5240 Circuit, Breathing (W Connector, Adaptor, Y Piece) Class 1 CAI
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
Relevant FDA Guidance and/or Supportive Publications
Draft Reviewer Guidance on Face Masks and Shield for CPR, March 1994

Draft reviewer guidance for ventilators July 1995

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

Draft Emergency Resuscitator Guidance, April 14, 1993
FDA Technical Contact
 Neel Patel
  FDA/OMPT/CDRH/ODE/DAGID/ANDB/
  301-796-6274
  Neel.Patel@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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