Recognized standard
9360-1 First edition 2000-03
FDA recognition 1-190 · ISO · Anesthesiology
Key facts
| Recognition number | 1-190 |
|---|---|
| Designation | 9360-1 First edition 2000-03 |
| Title | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including those incorporating breathing system filters, intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml, and… |
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: