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Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
03-12-2019
Language(s)
English, French
Published date
03-18-2016
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.
| DevelopmentNote |
Supersedes ISO/DIS 15225. (03/2016)
|
| DocumentType |
Standard
|
| Pages |
13
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| UNE-EN ISO 15225:2016 | Identical |
| NF EN ISO 15225 : 2017 | Identical |
| NBN EN ISO 15225 : 2016 | Identical |
| NEN EN ISO 15225 : 2016 | Identical |
| NS EN ISO 15225 : 2016 | Identical |
| I.S. EN ISO 15225:2016 | Identical |
| PN EN ISO 15225 : 2016 | Identical |
| SN EN ISO 15225:2016 | Identical |
| UNI CEI EN ISO 15225 : 2010 | Identical |
| AAMI ISO 15225 : 2016 | Identical |
| BS EN ISO 15225:2016 | Identical |
| CEI UNI EN ISO 15225 : 2ED 2016 | Identical |
| EN ISO 15225:2016 | Identical |
| DIN EN ISO 15225:2015-08 (Draft) | Identical |
| DIN EN ISO 15225:2000-11 | Identical |
| UNI EN ISO 15225 : 2006 | Identical |
| CEI UNI EN 15225 : 2010 | Identical |
| GOST ISO 15225 : 2011 | Identical |
| CSA ISO 15225 : 2001 | Identical |
| GOST R ISO 15225 : 2014 | Identical |
| DIN EN ISO 16278 E : 2016 | HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016) |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. CEN/TR 15133:2005 | NOMENCLATURE - COLLECTIVE TERMS AND CODES FOR GROUPS OF MEDICAL DEVICES |
| S.R. CWA 17028-401:2016 | BUSINESS INTEROPERABILITY INTERFACES FOR PUBLIC PROCUREMENT IN EUROPE - E-CATALOGUE - PART 401: GUIDELINE ON THE USAGE OF CLASSIFICATION SYSTEMS |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| BS EN 15521:2007 | Health informatics. Categorial structure for terminologies of human anatomy |
| 08/30154605 DC : DRAFT APR 2008 | BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
| BS ISO 7176-26:2007 | Wheelchairs Vocabulary |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| PD ISO/TS 19218-2:2012 | Medical devices. Hierarchical coding structure for adverse events Evaluation codes |
| 10/30195946 DC : DRAFT DEC 2010 | BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
| 03/318598 DC : DRAFT NOV 2003 | ISO TS 19218 - MEDICAL DEVICES - CODING SYSTEM FOR ADVERSE EVENT REPORTING |
| ISO 7176-26:2007 | Wheelchairs Part 26: Vocabulary |
| I.S. EN ISO 11073-20601:2016 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 20601: APPLICATION PROFILE - OPTIMIZED EXCHANGE PROTOCOL |
| ISO/TS 19218-1:2011 | Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
| DD ISO/TS 19218-1 : 2011 | MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES |
| CEI UNI EN 1041 : 2014 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. EN ISO 16278:2016 | HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016) |
| AAMI ISO 15223-2 : 2010 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| VDI/VDE 2426 Blatt 1:2000-05 | Catalogues in maintenance and management of medical devices - General |
| 06/30150535 DC : 0 | EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY |
| 14/30297307 DC : 0 | BS EN ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES SYSTEMS OF HUMAN ANATOMY |
| BS ISO 15223-2:2010 | Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation |
| 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 |
| AAMI ISO TIR 19218-2 : 2012 | MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 2: EVALUATION CODES |
| 09/30176675 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| 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 |
| ISO/TS 19218-2:2012 | Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes |
| ISO 27185:2012 | Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
| EN ISO 11073-10201:2005 | Health informatics - Point-of-care medical device communication - Part 10201: Domain information model (ISO/IEEE 11073-10201:2004) |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| 05/30128342 DC : DRAFT AUG 2005 | ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING, AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| PD CEN/TR 15133:2005 | Nomenclature. Collective terms and codes for groups of medical devices |
| 14/30302761 DC : 0 | BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS) |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| AAMI ISO 27185 : 2012 | CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| I.S. EN ISO 11073-10201:2005 | HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 10201: DOMAIN INFORMATION MODEL |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| BS EN 1041 : 2008 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| ISO/IEEE 11073-20601:2016 | Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol |
| EN ISO 11073-20601:2016 | Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016) |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 16278:2016 | Health informatics - Categorial structure for terminological systems of human anatomy (ISO 16278:2016) |
| EN 15521:2007 | Health informatics - Categorial structure for terminologies of human anatomy |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| DIN EN ISO 16278:2016-08 | HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016) |
| I.S. EN 15521:2007 | HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY |
| I.S. EN 980:2008 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS ISO 27185:2012 | Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements |
| BS EN ISO 11073-20601:2016 | Health informatics. Personal health device communication Application profile. Optimized exchange protocol |
| BS EN ISO 16278:2016 | Health informatics. Categorial structure for terminological systems of human anatomy |
| AAMI ISO TIR 19218-1 : 2011 | MEDICAL DEVICES - HIERARCHAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES |
| 06/30122245 DC : 0 | EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| ISO 11249:2018 | Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies |
| BS EN ISO 11073-10201:2005 | Health informatics. Point-of-care medical device communication Domain information model |
| IEEE 11073-20601-2014 REDLINE | IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| ISO 16278:2016 | Health informatics Categorial structure for terminological systems of human anatomy |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| DIN EN 15521:2008-02 | HEALTH INFORMATICS - CATEGORICAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY |
| 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 : DRAFT 1997 | MEDICAL INFORMATICS - CATEGORICAL 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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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
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