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16/30344636 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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
Available format(s)

Hardcopy , PDF

Superseded date

31-01-2018

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Message exchange format
4 Conformance terminology and context
   as it relates to the ISO IDMP standards and
   corresponding IDMP technical specifications
5 Terms, definitions and abbreviations
6 Requirements
7 Description of the information modelling
   principles and practices
8 Identifying characteristics for authorised
   Medicinal Products
9 Information for an authorised Medicinal
   Product
10 Identifying characteristics for Investigational
   Medicinal Products
11 Information for an Investigational
   Medicinal Product
Annex A (informative) - Full model - Authorised Medicinal
        Products detailed diagram
Annex B (informative) - Full model - Investigational Medicinal
        Products detailed diagram
Bibliography

BS EN ISO 11615.

Committee
²IST/35
DocumentType
Draft
Pages
92
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
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 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO/IEC 2382-4:1999 Information technology Vocabulary Part 4: Organization of data
ENV 12610 : DRAFT 1997 MEDICAL INFORMATICS - MEDICINAL PRODUCT IDENTIFICATION
ISO 639-2:1998 Codes for the representation of names of languages — Part 2: Alpha-3 code
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 1087-2:2000 Terminology work Vocabulary Part 2: Computer applications
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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