Recognized standard
18835 First Edition 2015-04-01
FDA recognition 1-114 · ISO · Anesthesiology
Key facts
| Recognition number | 1-114 |
|---|---|
| Designation | 18835 First Edition 2015-04-01 |
| Title | Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 18835:2015 specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia. Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents. ISO… |
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: