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  • ISO 11615:2017

    Current The latest, up-to-date edition.

    Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information

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

    Language(s):  English, French

    Published date:  19-10-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.

    Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.

    Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

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

    Committee ISO/TC 215
    Development Note Supersedes ISO/DIS 11615. (10/2017)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    S.R. CEN ISO/TS 20443:2018 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11615 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO/TS 20443:2017)
    BS EN ISO 11239:2012 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
    DIN EN ISO 11240:2013-03 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
    PD CEN ISO/TS 16791:2015 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
    14/30267009 DC : 0 BS EN ISO 17523 - HEALTH INFORMATICS - REQUIREMENTS FOR ELECTRONIC PRESCRIPTIONS
    UNE-EN ISO 11616:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)
    S.R. CEN ISO/TS 19256:2017 HEALTH INFORMATICS - REQUIREMENTS FOR MEDICINAL PRODUCT DICTIONARY SYSTEMS FOR HEALTH CARE (ISO/TS 19256:2016)
    S.R. CEN ISO/TS 16791:2015 HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS (ISO/TS 16791:2014)
    ISO/TR 23022:2018 Traditional Chinese medicine Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products
    CEN ISO/TS 19293:2018 Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018)
    PD CEN ISO/TS 17251:2016 Health informatics. Business requirements for a syntax to exchange structured dose information for medicinal products
    PD ISO/TS 20428:2017 Health informatics. Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
    17/30355946 DC : 0 BS ISO 21976 - PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
    ISO 11238:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
    BS EN ISO 13940:2016 Health informatics. System of concepts to support continuity of care
    CEN ISO/TS 20443:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)
    I.S. EN ISO 11238:2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
    UNE-EN ISO 11238:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
    UNI EN ISO 11238 : 2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES
    DIN EN ISO 11238:2013-03 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
    I.S. EN ISO 11616:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017)
    S.R. CEN ISO/TS 19293:2018 HEALTH INFORMATICS - REQUIREMENTS FOR A RECORD OF THE DISPENSE OF A MEDICINAL PRODUCT (ISO/TS 19293:2018)
    CEN ISO/TS 20451:2018 Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)
    ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
    ONORM ONR CEN ISO/TS 16791 : 2015 HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS (ISO/TS 16791:2014)
    S.R. CEN ISO/TS 20451:2018 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11616 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO/TS 20451:2017)
    ISO/TS 19844:2016 Health informatics Identification of medicinal products Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
    UNE-EN ISO 11240:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
    PD CEN ISO/TS 19256:2017 Health informatics. Requirements for medicinal product dictionary systems for health care
    BS PD ISO/TS 16791 : 2014 HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS
    I.S. EN ISO 13940:2016 HEALTH INFORMATICS - SYSTEM OF CONCEPTS TO SUPPORT CONTINUITY OF CARE (ISO 13940:2015)
    ISO/TS 18062:2016 Health informatics — Categorial structure for representation of herbal medicaments in terminological systems
    ISO/TS 19293:2018 Health informatics Requirements for a record of a dispense of a medicinal product
    EN ISO 11238:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012)
    PD CEN ISO/TS 19844:2015 Health informatics. Identification of medicinal products. Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
    BS EN ISO 11238:2012 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances
    CEN ISO/TS 16791:2015 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014)
    S.R. CEN ISO/TS 19844:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO/TS 19844:2016)
    BS EN ISO 11240:2012 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of units of measurement
    16/30344632 DC : 0 BS EN ISO 11616 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION
    16/30344636 DC : 0 BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION
    ISO/TS 20451:2017 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
    DIN EN ISO 11239:2013-03 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2012)
    PD ISO/TS 18062:2016 Health informatics. Categorial structure for representation of herbal medicaments in terminological systems
    UNE-EN ISO 11239:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2012)
    BS EN ISO 11616:2017 Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    CEN ISO/TS 19844:2017 Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016)
    EN ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
    ISO/TS 17251:2016 Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products
    ISO 17523:2016 Health informatics — Requirements for electronic prescriptions
    ISO/TS 19256:2016 Health informatics Requirements for medicinal product dictionary systems for health care
    EN ISO 17523:2016 Health informatics - Requirements for electronic prescriptions (ISO 17523:2016)
    EN ISO 11240:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
    EN ISO 11239:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2012)
    EN ISO 13940:2016 Health informatics - System of concepts to support continuity of care (ISO 13940:2015)
    UNE-EN ISO 13940:2016 Health informatics - System of concepts to support continuity of care (ISO 13940:2015)
    BS EN ISO 17523:2016 Health informatics. Requirements for electronic prescriptions
    PD CEN ISO/TS 20443:2018 Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
    BS ISO 18668-4:2017 Traditional Chinese medicine. Coding system for Chinese medicines Codes for granule forms of individual medicinals for prescriptions
    ISO 18668-4:2017 Traditional Chinese medicine — Coding system for Chinese medicines — Part 4: Codes for granule forms of individual medicinals for prescriptions
    UNI EN ISO 11239 : 2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON PHARMACEUTICAL DOSE FORMS, UNITS OF PRESENTATION, ROUTES OF ADMINISTRATION AND PACKAGING
    S.R. CEN ISO/TS 17251:2016 HEALTH INFORMATICS - BUSINESS REQUIREMENTS FOR A SYNTAX TO EXCHANGE STRUCTURED DOSE INFORMATION FOR MEDICINAL PRODUCTS (ISO/TS 17251:2016)
    UNI EN ISO 11240 : 2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT
    ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    I.S. EN ISO 11239:2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON PHARMACEUTICAL DOSE FORMS, UNITS OF PRESENTATION, ROUTES OF ADMINISTRATION AND PACKAGING (ISO 11239:2012)
    I.S. EN ISO 11240:2012 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT (ISO 11240:2012)
    I.S. EN ISO 17523:2016 HEALTH INFORMATICS - REQUIREMENTS FOR ELECTRONIC PRESCRIPTIONS (ISO 17523:2016)
    ISO/TS 20428:2017 Health informatics Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
    ISO/TS 20443:2017 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
    ISO 11239:2012 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
    ISO 13940:2015 Health informatics — System of concepts to support continuity of care
    CEN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)
    CEN ISO/TS 17251:2016 Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016)

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

    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    ISO 639-1:2002 Codes for the representation of names of languages — Part 1: Alpha-2 code
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    ISO/TS 19844:2016 Health informatics Identification of medicinal products Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
    ISO/IEC 15416:2016 Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols
    ISO/IEC TR 24720:2008 Information technology Automatic identification and data capture techniques Guidelines for direct part marking (DPM)
    ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
    ISO 21090:2011 Health informatics — Harmonized data types for information interchange
    ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
    ENV 13607:2000 HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS
    ISO 11238:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    ENV 12610 : DRAFT 1997 MEDICAL INFORMATICS - MEDICINAL PRODUCT IDENTIFICATION
    ISO/TS 20440:2016 Health informatics — Identification of medicinal products — Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
    ISO/IEC 11404:2007 Information technology — General-Purpose Datatypes (GPD)
    ISO/IEC TR 29158:2011 Information technology Automatic identification and data capture techniques Direct Part Mark (DPM) Quality Guideline
    ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
    ISO/HL7 27953-1:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting
    ISO/IEC 15415:2011 Information technology Automatic identification and data capture techniques Bar code symbol print quality test specification Two-dimensional symbols
    ISO/IEC 5218:2004 Information technology Codes for the representation of human sexes
    ISO 11239:2012 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
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