Recognized standard
10079-1 Fourth edition 2022-03
FDA recognition 1-157 · ISO · Anesthesiology
Key facts
| Recognition number | 1-157 |
|---|---|
| Designation | 10079-1 Fourth edition 2022-03 |
| Title | Medical suction equipment - Part 1: Electrically powered suction equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use. |
At a glance
- 10–99 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: