Recognized standard
5840-2 Second edition 2021-01 [Including AMD1:2025]
FDA recognition 3-206 · ISO · Cardiovascular
Key facts
| Recognition number | 3-206 |
|---|---|
| Designation | 5840-2 Second edition 2021-01 [Including AMD1:2025] |
| Title | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes [Including: AMENDMENT 1 (2025)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | May 25, 2026 |
| Device classes | Class 3 |
| Scope (excerpt) | This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both… |
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: