FDA-recognized standard · General I (QS/RM)
ISO 15223-1: Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)]
Yes. FDA recognizes ISO 15223-1 Fourth edition 2021-07 [Including AMD1: 2025] as recognition 5-148, entered 2025-12-22. FDA also lists ISO 15223-1 Fourth edition 2021-07 (recognition 5-134, transition period ending 2028-12-17).
Recognized editions of ISO 15223-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-148 | ISO 15223-1 Fourth edition 2021-07 [Including AMD1: 2025] | 2025-12-22 | Complete | — |
| 5-134 | ISO 15223-1 Fourth edition 2021-07 | 2021-12-20 | Complete | 2028-12-17 |
Product codes that cite ISO 15223-1
No product code cites ISO 15223-1: it is a horizontal standard, applied across device types rather than tied to particular codes.
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.