TS EN ISO 15225
Medical devices - Quality management - Medical device nomenclature data structure
This standard specifies rules and guidelines for a medical device nomenclature data
structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an
international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers,
healthcare providers and end users.
Available Formats:
- Availability: Immediate Download
- Language: English
- License Type: Single User
- Updates: Not Included
- Availability: Request Quote
- Language: English
- License Type: Enterprise / Multi User
- Updates: Included
About This Item
TS EN ISO 15225 is the Turkish adoption of the standard that defines the data structure used for medical device nomenclature. Its subject sits at the intersection of regulatory information management and device identification, where a device name must be represented in a consistent, exchangeable, and well-organised way for technical and regulatory use.
Why nomenclature data structures matter
The standard focuses on organising nomenclature data for medical devices so that it can be shared reliably among regulatory bodies, manufacturers, suppliers, healthcare providers, and end users. In general technical terms, a controlled data structure reduces ambiguity when the same product family may be described differently across countries, organisations, or information systems.
What the scope covers in practical terms
According to the supplied scope, this standard specifies rules and guidelines for a medical device nomenclature data structure. That means its role is to provide a common framework for how nomenclature information is arranged, identified, and exchanged. In broader domain context, such structures support product registration, database interoperability, traceability workflows, and regulatory communication, without being a technical performance standard for the devices themselves.
- Supports a common data language between regulatory authorities and other stakeholders.
- Addresses the structured representation of medical device names and terms.
- Facilitates international exchange of nomenclature data.
- Helps reduce inconsistencies caused by different naming practices in separate systems.
- Publication Date: 9.01.2017
- Standard Status: H (İptal Edilmiş Standard/Withdrawn standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 01.040.11 Sağlık Teknolojisi(Terimler); 01.040.35 Enformasyon Teknolojisi, Büro Makinaları (Terimler); 11.040.01 Tıbbi Ekipman (Genel); 35.240.80 Sağlık Teknolojisinde Enformasyon Teknolojisi Uygulamaları
- Pages: 25
- Source Standard: EN ISO 15225:2016
- International Equivalents: EN ISO 15225:2016-EQV; ISO 15225:2016-EQV
Need This Standard?
Request a personalized quote today to receive the latest edition in PDF or other available formats.
Need This Standard?
Request a personalized quote today to receive the latest edition in PDF or other available formats.
Summarize with AI
Get quick summaries using your favorite AI engine.
Online Standart Disclaimer
OnlineStandart.com is an authorized reseller of international standards, operating through partnerships with authorized distributors. We do not own the copyrights or trademarks of the standards we sell, including but not limited to those of API, ASHRAE, BSI, SAE, ASTM, IEEE, IEC, ASME, ISO, and others.
All product names, logos, and brands are the property of their respective owners and are used for identification purposes only; their use does not imply endorsement. OnlineStandart.com is not affiliated with or endorsed by any standards development organization unless explicitly stated. The content of this document is for informational purposes only and is intended to promote our licensed reselling services.
Online Standart does not host, distribute, or link to free, unlicensed, or uncertified copies of copyrighted standards. Every document we deliver is a licensed copy obtained through authorized channels and supplied with full licensing documentation. The “Free PDF Download” option on our product pages refers to this free informational document — never to a free copy of any standard.




