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I.S. EN ISO 15225:2016

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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)

Available format(s)

Hardcopy , PDF

Withdrawn date

05-13-2021

Language(s)

English

Published date

01-01-2016

Preview

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.

US$41.23
Excluding Tax where applicable

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Withdrawn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

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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