Recognized standard
5910 Second edition 2024-07
FDA recognition 3-195 · ISO · Cardiovascular
Key facts
| Recognition number | 3-195 |
|---|---|
| Designation | 5910 Second edition 2024-07 |
| Title | Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This document specifies an approach for verifying and validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification and validation tests and methods are derived from the risk assessment. The tests include assessments of… |
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: