Recognized standard
5362 Fifth edition 2024-07
FDA recognition 1-182 · ISO · Anesthesiology
Key facts
| Recognition number | 1-182 |
|---|---|
| Designation | 5362 Fifth edition 2024-07 |
| Title | Anaesthetic and respiratory equipment - Anaesthetic reservoir bags |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity. This document is not applicable to special-purpose bags, for example bellows… |
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: