TS EN ISO 15225

TS EN ISO 15225 specifies the technical features for establishing a nomenclature system for medical devices used in regulatory data exchange. As a terminology standard, it helps different organisations refer to the same device in a consistent way, supporting cataloguing, recordkeeping, data matching, and regulatory communication.

Purpose of a medical device nomenclature

The standard is concerned with how medical device names are structured rather than with individual product performance. In practical terms, a controlled nomenclature makes cross-border data exchange easier for regulatory authorities, manufacturers, suppliers, health care providers, and end users. In the broader technical context, this kind of structured terminology acts as a bridge between product classification and information systems, reducing ambiguity when the same device is described in different languages, databases, or regulatory workflows.

Why the distinction matters in healthcare information

In medical devices, naming is not just a labeling exercise; it is a core data layer for identification, traceability, and information management. A well-structured nomenclature supports more consistent searching, grouping, and comparison of products, and it improves the reliability of data exchanged between institutions. This standard addresses the specification and guidance for building that framework; it is not a product catalogue of individual devices.

• Provides a terminology framework intended to support international exchange of regulatory data.
• Sets out features and guidance for constructing consistent medical device nomenclature.
• Facilitates communication among regulatory authorities, manufacturers, suppliers, health care providers, and end users.
• Supports more consistent cataloguing, registration, and classification processes.