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BS EN ISO 11238:2018

BS EN ISO 11238:2018

$215.11

Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances

Published By Publication Date Number of Pages
BSI 2018 72
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
24 4 Symbols and abbreviated terms
27 5 Description of the information modelling principles and practices
5.1 General considerations
5.2 Conceptual overview diagrams
28 5.3 Section high-level diagrams
5.4 Detailed diagrams
29 5.5 Relationships between classes
31 5.6 Notes
5.7 Attributes
5.8 Message exchange format
32 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
34 6.3 Concepts required for the description of specified substances
36 6.3.1 Relationship between Substances and Specified Substance Groups
37 6.4 Naming of substances
38 6.5 Requirements for unique identifiers
6.6 Existing identifiers and molecular structure representation
39 7 Types of substances
7.1 General
7.2 Element sets common to multiple types of substances
7.2.1 Structure
7.2.2 Isotope
40 7.2.3 Modification
41 7.2.4 Reference information
42 7.2.5 Source material
43 7.2.6 Taxonomy
7.2.7 Authentication of Herbal Drugs
44 7.2.8 Substance codes
7.3 Chemical substances
45 7.4 Protein substances
47 7.5 Nucleic acid substances
48 7.6 Polymer substances
49 7.7 Structurally diverse substances
52 7.8 Mixture
53 8 Defining specified substances
8.1 General
54 8.2 Specified Substance Group 1
57 8.3 Specified Substance Group 2
59 8.4 Specified Substance Group 3
60 8.5 Specified Substance Group 4
8.5.1 General
8.5.2 Specified Substance Group 4 Name
61 8.5.3 Grade
8.5.4 Use of analytical data
62 8.5.5 Manufacturing
8.5.6 Version and specification
66 Annex A (informative) Existing identifiers and molecular structure representations
70 Bibliography

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BS EN ISO 11238:2018
$215.11