Recognized standard
10079-4 First edition 2021-08
FDA recognition 1-158 · ISO · Anesthesiology
Key facts
| Recognition number | 1-158 |
|---|---|
| Designation | 10079-4 First edition 2021-08 |
| Title | Medical suction equipment - Part 4: General requirements |
| 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 general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; b) syringes; c) dental… |
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: