Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)
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This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Description of the information modelling principles and practices
5.1 General considerations
5.2 Conceptual overview diagrams
5.3 Section high-level diagrams
5.4 Detailed diagrams
5.5 Relationships between classes
5.6 Notes
5.7 Attributes
5.8 Message exchange format
5.9 Conformance terminology and context as it relates to ISO 11238 and ISO/TS 19844
6 Requirements
6.1 General
6.2 Concepts required for the unique identification and description of substances
6.3 Concepts required for the description of specified substances
6.4 Naming of substances
6.5 Requirements for unique identifiers
6.6 Existing identifiers and molecular structure representation
7 Types of substances
7.1 General
7.2 Element sets common to multiple types of substances
7.3 Chemical substances
7.4 Protein substances
7.5 Nucleic acid substances
7.6 Polymer substances
7.7 Structurally diverse substances
7.8 Mixture
8 Defining specified substances
8.1 General
8.2 Specified Substance Group 1
8.3 Specified Substance Group 2
8.4 Specified Substance Group 3
8.5 Specified Substance Group 4
Annex A Existing identifiers and molecular structure representations (informative)
ISO/TS 19844:2018 Health informatics -- Identification of medicinal products (IDMP) -- Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances
ISO/TS 19844:2018 Health informatics -- Identification of medicinal products (IDMP) -- Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances