16/30344636 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Hardcopy , PDF
31-01-2018
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Superseded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 12610:1997 | 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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