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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  12-03-2019

    Language(s):  English, French

    Published date:  18-03-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 15225. (03/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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