TS EN ISO 15225

TS EN ISO 15225 addresses the technical specification and guidance for building a nomenclature system used in regulatory data exchange for medical devices. It aims to establish a common terminology so that regulatory authorities, manufacturers, suppliers, health care providers, and end users can identify the same device under a shared naming structure.

Why nomenclature matters for medical devices

In the medical device field, nomenclature is more than product naming; it is the framework that supports classification, data integrity, and consistent communication across organisations. In regulatory data exchange, a controlled terminology helps product records, approval workflows, cataloguing, and information systems remain aligned. It also makes it easier to trace and compare the same device across different languages and institutional contexts.

The technical role covered by this standard

The focus of this standard is the construction of a nomenclature for medical devices, together with guidance on how such a terminology should be organised. In general technical terms, nomenclature systems are used to structure terms, distinguish concepts, define relationships, and support unambiguous exchange of data. The standard provides a conceptual framework for interoperability in health technology information systems; based on the supplied information, it does not support attributing a specific test method or numerical performance limit to this document.

A controlled nomenclature reduces confusion caused by free-text product naming and supports more orderly regulatory records. Because medical devices range from simple consumables to complex active systems, a clear and consistent terminology is especially valuable for international communication and data management.