Recognized standard
18190 First edition 2016-11-01
FDA recognition 1-120 · ISO · Anesthesiology
Key facts
| Recognition number | 1-120 |
|---|---|
| Designation | 18190 First edition 2016-11-01 |
| Title | Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: