Recognized standard
5362 Fourth edition 2006-06-01 5362:2006
FDA recognition 1-75 · ISO · Anesthesiology
Key facts
| Recognition number | 1-75 |
|---|---|
| Designation | 5362 Fourth edition 2006-06-01 5362:2006 |
| Title | Anaesthetic Reservoir Bags |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 1 |
| Scope (excerpt) | ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance. ISO… |
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: