AAMI 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
29-11-2017
English
01-01-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 15225:2016
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.
| Committee |
WG 03
|
| DocumentType |
Standard
|
| Pages |
23
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 15225:2016 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.