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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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)
31-10-2016
06-04-2016
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
ISO 15225:2016 specifies 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.ISO 15225:2016 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.
| Committee |
CEN/CLC/JTC 3
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DIN EN ISO 15225:2000-11 | Identical |
| BS EN ISO 15225:2016 | Identical |
| NF EN ISO 15225 : 2017 | Identical |
| NS EN ISO 15225 : 2016 | Identical |
| UNI CEI EN ISO 15225 : 2010 | 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 |
| PN EN ISO 15225 : 2016 | Identical |
| DIN EN ISO 15225:2015-08 (Draft) | Identical |
| CEI UNI EN 15225 : 2010 | Identical |
| CEI UNI EN ISO 15225 : 2ED 2016 | Identical |
| NEN EN ISO 15225 : 2016 | Identical |
| I.S. EN ISO 15225:2016 | Identical |
| ISO 15225:2016 | Identical |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 06/30123163 DC : 0 | BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
| I.S. CEN/TR 15133:2005 | NOMENCLATURE - COLLECTIVE TERMS AND CODES FOR GROUPS OF MEDICAL DEVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| PD CR 14230:2001 | Global medical device nomenclature for the purpose of regulatory data exchange |
| UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 03/314031 DC : DRAFT AUG 2003 | BS ISO 7176-26 - WHEELCHAIRS - PART 26: VOCABULARY |
| CR 14230 : 2001 | GLOBAL MEDICAL DEVICE NOMENCLATURE FOR THE PURPOSE OF REGULATORY DATA EXCHANGE |
| CEI UNI EN 1041 : 2014 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| PD CEN/TR 15133:2005 | Nomenclature. Collective terms and codes for groups of medical devices |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 09/30205582 DC : 0 | BS EN 15986 - SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. CR 14230:2001 | GLOBAL MEDICAL DEVICE NOMENCLATURE FOR THE PURPOSE OF REGULATORY DATA EXCHANGE |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| BS EN 1041 : 2008 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| EN 16372:2014 | Aesthetic surgery services |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| I.S. EN 980:2008 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| BS EN 16372:2014 | Aesthetic surgery services |
| 06/30122245 DC : 0 | EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| CEN/TR 15133:2005 | Nomenclature - Collective terms and codes for groups of medical devices |
| 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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