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BS EN ISO 15225 : 2016

M00016169

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BS EN ISO 15225 : 2016

MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Principle of structure<br>5 Data file dictionary<br>Annex A (informative) - Examples for generation of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;generic device group terms and synonyms<br>Annex B (informative) - Example of term record<br>Annex C (informative) - Examples of collective terms<br>Annex D (informative) - Examples of top-level collective<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;term nodes<br>Bibliography

Abstract

Describes 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.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/210/3
Supersedes
  • 15/30280234 DC : 0
  • 96/562391 DC : JUL 96
  • 02/560714 DC : DRAFT MAR 2002
  • 08/30159296 DC : DRAFT APR 2008