ISO 11615:2017
Current
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
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
10-19-2017
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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.
| Committee |
ISO/TC 215
|
| DevelopmentNote |
Supersedes ISO/DIS 11615. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
79
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 11615:2018 | Identical |
| DIN EN ISO 11615:2018-04 | Identical |
| BS EN ISO 11615:2012 | Identical |
| EN ISO 11615:2017 | Identical |
| DIN EN ISO 11615:2016-09 (Draft) | Identical |
| UNI EN ISO 11615 : 2012 | Identical |
| IS/ISO 11615 : 2017 | Identical |
| SN EN ISO 11615 : 2013 | Identical |
| BS EN ISO 11615:2017 | Identical |
| ONORM EN ISO 11615 : 2018 | Identical |
| NS EN ISO 11615 : 2017 | Identical |
| NBN EN ISO 11615 : 2013 | Identical |
| I.S. EN ISO 11615:2017 | Identical |
| PN EN ISO 11615 : 2018 | Identical |
| NEN EN ISO 11615 : 2018 | Identical |
| UNE-EN ISO 11615:2013 | Identical |
| NF EN ISO 11615 : 2018 | Identical |
| GOST R ISO 11615 : 2014 | Identical |
| UNE-EN ISO 11615:2018 | Identical |
| DS EN ISO 11615 : 2017 | Identical |
| 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) |
| 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 12610:1997 | 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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