I.S. EN ISO 15225:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE (ISO 15225:2016)
Hardcopy , PDF
13-05-2021
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle of structure
5 Data file dictionary
Annex A (informative) - Examples for generation of
generic device group terms and synonyms
Annex B (informative) - Example of term record
Annex C (informative) - Examples of collective terms
Annex D (informative) - Examples of top-level collective
term nodes
Bibliography
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.
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 15225 : 2017 | Identical |
| NS EN ISO 15225 : 2016 | Identical |
| UNI EN ISO 15225 : 2006 | Identical |
| NBN EN ISO 15225 : 2016 | Identical |
| UNE-EN ISO 15225:2016 | Identical |
| SN EN ISO 15225:2016 | Identical |
| DIN EN ISO 15225:2015-08 (Draft) | Identical |
| NEN EN ISO 15225 : 2016 | Identical |
| EN ISO 15225:2016 | Identical |
| ISO 15225:2016 | Identical |
| BS EN ISO 15225:2016 | Identical |
| DIN EN ISO 15225:2000-11 | Identical |
| ISO 1087-1:2000 | Terminology work Vocabulary Part 1: Theory and application |
| ISO/IEC 8859-1:1998 | Information technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 1 |
| ENV 12611:1997 | Medical informatics - Categorial structure of systems of concepts - Medical devices |
| ISO 25964-1:2011 | Information and documentation — Thesauri and interoperability with other vocabularies — Part 1: Thesauri for information retrieval |
| ISO 1942:2009 | Dentistry Vocabulary |
| ISO 25964-2:2013 | Information and documentation — Thesauri and interoperability with other vocabularies — Part 2: Interoperability with other vocabularies |
| ISO/IEC 2382:2015 | Information technology — Vocabulary |
| ISO 10241-1:2011 | Terminological entries in standards — Part 1: General requirements and examples of presentation |
| ISO 9999:2016 | Assistive products for persons with disability Classification and terminology |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
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