Recognized standard
/PAS 7020 First edition 2023-05
FDA recognition 3-190 · ISO · Cardiovascular
Key facts
| Recognition number | 3-190 |
|---|---|
| Designation | /PAS 7020 First edition 2023-05 |
| Title | Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 3 |
| Scope (excerpt) | This document describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned… |
At a glance
- None 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: