Recognized standard
23747 Second edition 2015-08
FDA recognition 1-178 · ISO · Anesthesiology
Key facts
| Recognition number | 1-178 |
|---|---|
| Designation | 23747 Second edition 2015-08 |
| Title | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an… |
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: