Recognized standard
11712 First edition 2009-05-15
FDA recognition 1-126 · ISO · Anesthesiology
Key facts
| Recognition number | 1-126 |
|---|---|
| Designation | 11712 First edition 2009-05-15 |
| Title | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 11712:2009 provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. ISO 11712:2009… |
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: