DIN EN ISO 15223-1:2026-09

What is DIN EN ISO 15223-1 about?

DIN EN ISO 15223-1 specifies internationally recognized symbols for the labelling of medical devices. The standard describes graphical symbols that manufacturers can use on medical devices, packaging and accompanying information to communicate important information independently of language and in a way that is understood worldwide.

The aim of the standard is to harmonize the labelling of medical devices and improve the clarity of information on safety, use, storage, sterility and traceability. The standard supports the requirements of the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

What content does the standard cover?

DIN EN ISO 15223-1 defines requirements for the use of symbols and includes standardized labelling symbols for medical devices and in vitro diagnostics. It also describes their application on labels, packaging and accompanying information.

Topics covered at a glance:

• Symbols for manufacturers, authorized representatives, importers and distributors
• Labelling of date of manufacture, use-by date, batch and serial numbers
• Symbols for sterility and sterilization methods
• Storage and transport conditions, e.g. temperature, humidity and pressure limits
• Safety and warning information for the use of medical devices
• Symbols for UDI labelling, patient information and traceability
• Specific labelling for in vitro diagnostics (IVD)

Why is the standard relevant in practice?

DIN EN ISO 15223-1 provides a uniform basis for the labelling of medical devices and helps manufacturers implement regulatory requirements efficiently. The use of standardized symbols enables important information to be communicated clearly, regardless of language or national markets.

The standard is particularly relevant for implementing the requirements of the EU Medical Device Regulation (MDR 2017/745) and IVDR 2017/746. It helps increase user safety and prevent errors caused by unclear labelling.

What changes have been made compared with the previous edition?

Compared with DIN EN ISO 15223-1:2022-02, the following changes have been made:

• Update of Annex ZA on MDR conformity
• Inclusion of the new term “authorized representative” (Clause 3.20)
• Adaptation of symbol 5.1.2 “authorized representative” in Table 1
• Revision of the example for using the “authorized representative” symbol in Annex A.4
• Editorial revision of the document

The basic requirements and symbols of the standard remain largely unchanged.

Target audience

• Manufacturers of medical devices and in vitro diagnostics
• Regulatory affairs managers
• Quality managers in healthcare
• Specialists in product labelling and packaging design
• Notified bodies and certification organizations
• Auditors and compliance officers in the medical device sector

Conclusion

DIN EN ISO 15223-1 is the central standard for symbols on medical devices and their labelling. It defines internationally recognized symbols for manufacturer information, sterility, safety, storage, traceability and regulatory information. In this way, it supports globally understandable, standards-compliant and MDR-compliant product labelling for medical devices and in vitro diagnostics.

This document replaces DIN EN ISO 15223-1:2022-02 .