TS EN ISO 15225:2010 PDF | Request Standard

TS EN ISO 15225:2010

Medical devices - Quality management - Medical device nomenclature data structure

Standard by TSE, 22.11.2011

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  • Language: English
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About This Item

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TS EN ISO 15225:2010 is the Turkish listing for a standard focused on the nomenclature data structure used for regular exchange of information about medical devices, placed in a quality management context. In practical terms, this subject is about organizing device names, definitions and classification relationships so that records can be exchanged consistently across information systems, manufacturers, distributors, healthcare institutions and regulatory databases.

How a nomenclature data structure supports medical device information

Medical device nomenclature is broader than a product label. It aims to provide a controlled term structure that can describe a device by family, technical characteristics, intended use or clinical area. Such structures reduce the ambiguity that appears when the same item is described differently across countries or databases, and they support search, matching, reporting and inventory control. In general technical terms, standards of this kind help keep terminology hierarchical or coded in a predictable form; however, the detailed clause-by-clause content of this listing is not provided here.

Why this matters for quality management and data exchange

From a quality management perspective, nomenclature is part of data quality, not just naming. Consistent terminology helps reduce mismatches, strengthens traceability of product records and supports interoperability between information systems. For medical devices, such a data structure can provide a common language for cataloguing, clinical inventory, market surveillance and electronic data transfer. Based on the title, the central focus is the organization of the data that describes devices, rather than the devices themselves.

This record belongs to a withdrawn standard, so the text above is general technical background aligned with the title rather than a reproduction of the full standard’s provisions. When evaluating medical device nomenclature systems, the exact scope, coding logic and data-field organization should always be confirmed against the official edition.

SKU: 1d4b3efbeccf

  • Publication Date: 22.11.2011
  • 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: 31
  • Source Standard: EN ISO 15225:2010
  • International Equivalents:

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