| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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028
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Date of Entry 03/16/2012
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FR Recognition Number
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1-62
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| Standard | |
ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets |
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Identical AdoptionANSI AAMI ISO 5356-1:2004
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets |
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Scope/AbstractISO 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. |
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| Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5160 |
Gas-Machine, Anesthesia
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Class 2
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BSZ
|
| §868.5240 |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
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Class 1
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CAI
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| §868.5260 |
Filter, Bacterial, Breathing-Circuit
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Class 2
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CAH
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| §868.5375 |
Condenser, Heat And Moisture (Artificial Nose)
|
Class 1
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BYD
|
| §868.5450 |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
Class 2
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BTT
|
| §868.5720 |
Tube, Bronchial (W/Wo Connector)
|
Class 2
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BTS
|
| §868.5730 |
Tube, Tracheal (W/Wo Connector)
|
Class 2
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BTR
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| §868.5740 |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
Class 2
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CBI
|
| §868.5800 |
Tube, Tracheostomy (W/Wo Connector)
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Class 2
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BTO
|
| §868.5800 |
Tube Tracheostomy And Tube Cuff
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Class 2
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JOH
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| §868.5810 |
Connector, Airway (Extension)
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Class 1
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BZA
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| §868.5870 |
Valve, Non-Rebreathing
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Class 2
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CBP
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| §868.5895 |
Ventilator, Continuous, Facility Use
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Class 2
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CBK
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| §868.5895 |
Ventilator, Continuous, Non-Life-Supporting
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Class 2
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MNS
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| §868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
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Class 2
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MNT
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| §868.5905 |
Ventilator, Non-Continuous (Respirator)
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Class 2
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BZD
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| §868.5915 |
Ventilator, Emergency, Manual (Resuscitator)
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Class 2
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BTM
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| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator)
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Class 2
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BTL
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| §868.5965 |
Attachment, Breathing, Positive End Expiratory Pressure
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Class 2
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BYE
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| §868.5975 |
Set, Tubing And Support, Ventilator (W Harness)
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Class 1
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BZO
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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