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UNI EN ISO 15225 : 2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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NOMENCLATURE - SPECIFICATION FOR A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE

Superseded date

01-09-2022

Published date

01-01-2006

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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Principle of structure
5 Requirements
6 Data file dictionary
Annex A (normative) Device categories description
Annex B (informative) Examples for generation of generic
                      device group terms and synonyms
Annex C (informative) Examples of generic device group records
Annex ZA (informative) Relationship of this document with EC
                       Directives
Annex ZB (informative) Clauses of this European Standard
                       addressing essential requirements or
                       other provisions of Council Directive
                       90/385/EEC relating to active
                       implantable medical devices
Bibliography

Defines requirements and guidance for constructing a nomenclature for medical devices so as to facilitate cooperation and exchange of regulatory data on an international level between interested parties, eg Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers and End Users.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy

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