| ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| Recognition Number | Anesthesiology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 1-120 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
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 18190:2016 specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that reference it.
The requirements of a device-specific standard take priority over ISO 18190:2016.
NOTE General requirements contained in ISO 18190:2016 have historically been referenced in more than two other airways and related equipment standards.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5800 | Tube Tracheostomy And Tube Cuff | Class 2 | JOH |
| §868.5800 | Tube, Tracheostomy (W/Wo Connector) | Class 2 | BTO |
| §868.5730 | Tube, Tracheal (W/Wo Connector) | Class 2 | BTR |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015. |