Recognized standard
4135 Fourth edition 2022-01
FDA recognition 1-189 · ISO · Anesthesiology
Key facts
| Recognition number | 1-189 |
|---|---|
| Designation | 4135 Fourth edition 2022-01 |
| Title | Anaesthetic and respiratory equipment - Vocabulary |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2, Class 1, Class 3 |
| Scope (excerpt) | This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems. NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a 'general'… |
At a glance
- 10–99 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: