Recognized standard
15223-1 Fourth edition 2021-07 [Including AMD1: 2025]
FDA recognition 5-148 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-148 |
|---|---|
| Designation | 15223-1 Fourth edition 2021-07 [Including AMD1: 2025] |
| Title | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)] |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical… |
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: