FDA-recognized standard · Cardiovascular
ISO 5840-1: Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements [Including: AMENDMENT 1 (2025)]
Yes. FDA recognizes ISO 5840-1 Second edition 2021-01 01 [Including AMD1:2025] as recognition 3-205, in part, entered 2026-05-25. FDA also lists ISO 5840-1 Second edition 2021-01 (recognition 3-174, transition period ending 2028-07-02).
Recognized editions of ISO 5840-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-205 | ISO 5840-1 Second edition 2021-01 01 [Including AMD1:2025] | 2026-05-25 | Partial | — |
| 3-174 | ISO 5840-1 Second edition 2021-01 | 2021-12-20 | Partial | 2028-07-02 |
What FDA does not recognize in ISO 5840-1 Second edition 2021-01 01 [Including AMD1:2025]
Recognition 3-205 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Section 7.2.5.3 Device structural component fatigue assessment Annex J.3.1 General
What FDA does not recognize in ISO 5840-1 Second edition 2021-01
Recognition 3-174 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: -7.2.5.3 Device structural component fatigue assessment -Annex J.3.1 General
Regulations
FDA lists these classification regulations against ISO 5840-1: 21 CFR 870.3925.
Product codes that cite ISO 5840-1
7 FDA product codes cite ISO 5840-1, including DYE, HDE, LWQ, LWR, NPT.
- DYE
- HDE
- LWQ
- LWR
- NPT
- NPU
- NPV
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.