ISO 15223-1 “Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements” specifies standard symbols that may be used on medical device labels, packaging and instructions for use. This page introduces the key points of the 2021 edition and Amendment 1:2025 (Amd 1:2025), and where to obtain the official text.
About the standard
ISO 15223-1:2021 adds symbols supporting the EU MDR/IVDR to the 2016 edition, such as “Medical device (MD)”, “Unique device identifier (UDI)”, “Importer”, “Distributor” and “Patient information website”. It is the standard most often cited in labelling design for medical devices on the EU market, corresponding to the EU harmonised standard EN ISO 15223-1. Amendment 1:2025 supplements and revises some symbols and descriptions, and companies should assess its impact when updating labels.
Applicable products and users
- All medical devices and in vitro diagnostic (IVD) products that use symbols on labels, packaging or instructions for use
- Manufacturers preparing EU MDR/IVDR-compliant labelling
Main contents
- Graphics, meanings and conditions of use of standard symbols
- New symbols supporting the MDR/IVDR in the 2021 edition (MD, UDI, importer, etc.)
- Main changes in the 2025 amendment
- How symbol explanations are presented in the instructions for use
Where to obtain the official standard
This standard is a copyrighted publication of the International Organization for Standardization (ISO) and related standards bodies. Please purchase or consult the official text through the following official channels:
- ISO Store: ISO 15223-1:2021
- BSI Knowledge (British Standards Institution): BS EN ISO 15223-1
- Corresponding Chinese industry standard YY/T 0466.1 (official Chinese standards search platform)
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