Recognized standard
9360-2 First edition 2001-07
FDA recognition 1-191 · ISO · Anesthesiology
Key facts
| Recognition number | 1-191 |
|---|---|
| Designation | 9360-2 First edition 2001-07 |
| Title | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having 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 is based on ISO 9360-1:2000 and specifies certain requirements and test methods for heat and moisture exchangers (HMEs) without machine connector ports, including those incorporating breathing system filters. These devices are intended for the humidification of respired gases… |
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: