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Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 1-62: ISO 5356-1 Third edition 2004-05-15, anaesthetic and respiratory equipment - conical connectors: part 1: cones and sockets. (Anesthesias)

Date of Standard: 2004. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Anaesthetic and respiratory equipment -- conical connectors. Breathing circuits, ventilator tubing, tracheal tubes, tracheostomy tubes, bronchial tubes, PEEP valves, anesthesia gas machines, ventilators, manual emergency ventilators, powered emergency ventilators, airway connectors, bacterial filters, respiratory gas humidifiers, airway connectors and nonrebreathing valves.
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§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 And Tube Cuff Class 2 JOH
§868.5800 Tube, Tracheostomy (W/Wo Connector) Class 2 BTO
§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, Minimal Ventilatory Support,Facility Use Class 2 MNT
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§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 Guidance:
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:
 Nayan Patel
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2550
  Silver Spring MD 20993
  301/796-4110
  email: nayan.patel@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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