UNI EN ISO 15225 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-09-2022
01-01-2006
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Superseded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 |
Standards | Relationship |
SN EN ISO 15225:2016 | Identical |
DIN EN ISO 15225:2015-08 (Draft) | Identical |
NF EN ISO 15225 : 2017 | Identical |
NS EN ISO 15225 : 2016 | Identical |
NEN EN ISO 15225 : 2016 | Identical |
I.S. EN ISO 15225:2016 | Identical |
BS EN ISO 15225:2016 | Identical |
EN ISO 15225:2016 | Identical |
NBN EN ISO 15225 : 2016 | Identical |
UNE-EN ISO 15225:2016 | Identical |
ISO 15225:2016 | Identical |
DIN EN ISO 15225:2000-11 | Identical |
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