Recognized standard
10079-2 Fourth edition 2022-03
FDA recognition 1-155 · ISO · Anesthesiology
Key facts
| Recognition number | 1-155 |
|---|---|
| Designation | 10079-2 Fourth edition 2022-03 |
| Title | Medical suction equipment - Part 2: Manually powered suction equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2, Class 3, Class 1 |
| Scope (excerpt) | This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often… |
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: