Recognized standard
11712 Second edition 2023-11
FDA recognition 1-172 · ISO · Anesthesiology
Key facts
| Recognition number | 1-172 |
|---|---|
| Designation | 11712 Second edition 2023-11 |
| Title | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | This document provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to provide a distinct respiratory pathway to the top of the larynx to provide an unobstructed airway in patients during spontaneous, assisted or controlled… |
At a glance
- None 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: