Recognized standard
26782 First edition 2009-07
FDA recognition 1-179 · ISO · Anesthesiology
Key facts
| Recognition number | 1-179 |
|---|---|
| Designation | 26782 First edition 2009-07 |
| Title | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg. ISO 26782:2009 applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone… |
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: