| ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 1-62 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | Neel Patel FDA/OMPT/CDRH/ODE/DAGID/ANDB/ 301-796-6274 Neel.Patel@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II, Issued February 1989. |