| ISO 18082 First edition 2014-06-15 Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)] |
| Recognition Number | Anesthesiology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 1-130 |
| 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 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute.
ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases:
-oxygen;
-nitrous oxide;
-medical air;
-helium;
-carbon dioxide;
-xenon;
-specified mixtures of the gases listed above;
-oxygen-enriched air;
-air for driving surgical tools;
-nitrogen for driving surgical tools;
-use with vacuum.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5895 | Ventilator, Continuous, Facility Use | Class 2 | CBK |
| §868.5895 | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use | Class 2 | MNT |
| §868.5750 | Cuff, Tracheal Tube, Inflatable | Class 2 | BSK |
| §868.2700 | Regulator, Pressure, Gas Cylinder | Class 1 | CAN |
| There is no relevant guidance developed at this time. |