Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Lists symbols used on device labels and in the information supplied by the manufacturer.
The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| European Union | Harmonized | EN ISO 15223-1:2021 with amendment A1:2025 (ISO 15223-1:2021) | - | Recognition number MDR entry 12a; IVDR entry 8a. Effective January 5, 2022. Transition until June 15, 2031. The earlier reference without the 2025 amendment is deleted from this date. For in vitro diagnostic devices the date is 2031-06-17.. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
| United Kingdom | Recognized |
Related standards: EN 1041, ISO 18113-1, ISO 18113-2, ISO 18113-3, ISO 18113-4, ISO 18113-5. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| EN ISO 15223-1:2021 |
| - |
| Recognition number List row 163. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |