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DD ENV 12610:1998

Current
Current

The latest, up-to-date edition.

Medical informatics. Medical product identification
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-15-1998

Content
0. Foreword
    0.0 Mandate and Task Description
    0.1 Domain Description
    0.2 Structure of the document
    0.3 Users of the Prestandard
    0.4 Further developments
1. Scope
2. Normative References
3. Definitions (Normative)
4. Identifying Characteristics (Normative)
    4.0 Introduction
    4.1 Characteristics related to the ingredients
         4.1.0 Pharmaceutical class
         4.1.1 Ingredient designation
                4.1.1.0 Ingredient name
                4.1.1.1 Ingredient code value
         4.1.2 Ingredient manufacturer
         4.1.3 Ingredient batch number
         4.1.4 Ingredient description
         4.1.5 Ingredient territory
    4.2 Characteristics related to the pharmaceutical and the
         medicinal product
         4.2.0 Therapeutic group
         4.2.1 Medicinal product designation
                4.2.1.0 Medicinal product name
                4.2.1.1 Medicinal product code value
                4.2.1.2 Medicinal product name spoecifiers
         4.2.2 Marketing authorisation holder
         4.2.3 Marketing authorisation number
         4.2.4 Pharmaceutical product manufacturer
         4.2.5 Medicinal product manufacturer
         4.2.6 Strength
         4.2.7 Pharmaceutical form
         4.2.8 Dosage form
         4.2.9 Pharmaceutical product description
         4.2.10 Imprint
         4.2.11 Medicinal product batch number
         4.2.12 Pharmaceutical product batch number
         4.2.13 Medicinal product cluster
         4.2.14 Route of administration
         4.2.15 Medicinal product territory
    4.3 Characteristics related to the medicinal product
         packages
         4.3.0 Medicinal product package designation
         4.3.1 Medicinal product package responsible body
         4.3.2 Medicinal product package authorisation
                number
         4.3.3 Medicinal product package batch number
         4.3.4 Medicinal product package content
         4.3.5 Medicinal product package manufacturer
         4.3.6 Medicinal product package cluster
         4.3.7 Medicinal product package label
         4.3.8 Medicinal product package territory
    4.4 Overview of Identifying Concepts
5. Identifiers (Informative)
    5.0 Introduction
    5.1 Ingredient Identifiers
    5.2 Medicinal Product Identifiers
    5.3 Medicinal Product Package Identifiers
6. Conformity to the Standard
Annex A - List of Identifying Concepts
Annex B - List of Identifiers as proposed in this document
Annex C - Model Representation (Informative)
Annex D - Structure for a Concept System (Informative)
          D.0 Introduction
          D.1 Conceptual model at ingredient level
          D.2 Conceptual model at medicinal product level
          D.3 Conceptual model at medicinal package level
Annex E - Acronyms
Annex F - PT2-014 Team
Annex G - Index

Defines the semantic categories that are related to the identification of medicinal products and to establish a categorial structure that allows the description of the organisation of the semantic categories that represent the underlying system of characteristics.

Committee
IST/35
DocumentType
Standard
Pages
56
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ENV 12610 : DRAFT 1997 Identical

ENV 1614 : 1995 HEALTHCARE INFORMATICS - STRUCTURE FOR NOMENCLATURE, CLASSIFICATION AND CODING OF PROPERTIES IN CLINICAL LABORATORY SCIENCE
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO/IEC 2382-4:1999 Information technology Vocabulary Part 4: Organization of data
ISO 1087:1990 Terminology — Vocabulary
ENV 1068 : 1993 MEDICAL INFORMATICS - HEALTHCARE INFORMATION INTERCHANGE - REGISTRATION OF CODING SCHEMES

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