TS EN ISO 15225

TS EN ISO 15225 is a terminology standard concerned with how a nomenclature system for medical devices is specified for regulatory data exchange. Standards of this kind aim to let manufacturers, authorities, and information systems describe products through the same concepts, improving consistency in registration, tracking, reporting, and data exchange. This document is withdrawn, but it remains relevant as a reference point for understanding the role of device nomenclature in regulatory information flows.

What a medical device nomenclature system does

In general technical practice, nomenclature systems create a shared language between individual product names and broader product categories. In the medical device field, that shared language helps define what a device is, what it is used for, and how it differs from related products in technical terms. In regulatory data exchange, this consistency reduces mapping problems between databases and registration systems and supports information exchange across organizations and jurisdictions.

What this standard focuses on

Based on the supplied title and scope information, this document defines the specification for a nomenclature system for medical devices, meaning the framework for organising terms, classifying them, and using them in regulatory data exchange. The central idea is not a trade name but a standardised naming logic suitable for regulatory and technical communication. That makes it especially relevant to product registration, inventory management, recall workflows, and integration across multiple data systems.