Recognized standard
16571 Second edition 2024-03
FDA recognition 6-503 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-503 |
|---|---|
| Designation | 16571 Second edition 2024-03 |
| Title | Systems for evacuation of plume generated by medical device |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices. This document applies to all types of plume evacuation systems (PESs), including a) portable; b) mobile; c) stationary, including dedicated central pipelines; d) PESs… |
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: