TS EN ISO 15225

TS EN ISO 15225 is a standard dealing with the data structure used for medical device nomenclature, helping organise terms and names in a consistent way. Its scope defines rules and guidelines for a nomenclature data structure intended to facilitate data exchange among regulatory bodies and other interested parties, including manufacturers, suppliers, healthcare providers and end users. In other words, the standard is concerned with how medical-device-related information is structured and shared, rather than with the technical performance of the devices themselves.

Why a nomenclature data structure matters

In general technical practice, a medical device nomenclature provides a common language for identifying and grouping devices consistently. This reduces ambiguity when the same product family may be described differently by different organisations or in different databases. Such data structures are typically relevant in product registration, regulatory information systems, reporting workflows and supply-chain data exchange. The ISO 15225 subject area therefore sits at the intersection of terminology management, information governance and medical-device regulation.

What this document covers and what it does not

• It is intended to support international exchange of medical device nomenclature data between relevant parties.
• It addresses regulatory authorities, manufacturers, suppliers, healthcare providers and end users as part of that exchange context.
• It focuses on the structure and organisation of nomenclature data, not on the design or clinical performance of medical devices.
• This listing refers to a withdrawn TSE edition of the standard.

For organisations working with medical device data, TS EN ISO 15225 is valuable as a framework for consistent naming and structured information exchange. Its main contribution is conceptual and administrative: helping different stakeholders refer to devices in a compatible, machine-usable, and standardised way within the broader medical technology environment.