| CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 1-81 |
| Extent | Complete standard |
| Standards Orgs | CGA Compressed Gas Associated, Incorporated https://www.cganet.com/ |
| STG | Anesthesiology |
| FDA Tech | Jennifer E. Danieley FDA/OMPT/CDRH/OC 301-796-0309 jennifer.danieley@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.
Provides dimensions and other data to produce or use medical designed fittings for various gas connections used in hospital or patient care applications. The fittings are gas specific and noninterchangeable. This will avoid cross-connection of medical gases.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5925 | Ventilator, Emergency, Powered (Resuscitator) | Class 2 | BTL |
| §868.5160 | Gas-Machine, Anesthesia | Class 2 | BSZ |
| §868.2700 | Regulator, Pressure, Gas Cylinder | Class 1 | CAN |
| Draft Emergency Resuscitator Guidance, April 1993 Draft Reviewer Guidance for Ventilators, July 1995 |