Recognized standard
5840-1 Second edition 2021-01 01 [Including AMD1:2025]
FDA recognition 3-205 · ISO · Cardiovascular
Key facts
| Recognition number | 3-205 |
|---|---|
| Designation | 5840-1 Second edition 2021-01 01 [Including AMD1:2025] |
| Title | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements [Including: AMENDMENT 1 (2025)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | May 25, 2026 |
| Device classes | Class 3, HDE |
| Scope (excerpt) | This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices… |
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: