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BS EN ISO 11238:2018 – TC:2020 Edition

BS EN ISO 11238:2018 – TC:2020 Edition

$280.87

Tracked Changes. 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 2020 169
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PDF Catalog

PDF Pages PDF Title
99 National foreword
101 European foreword
104 Foreword
105 Introduction
108 1 Scope
2 Normative references
3 Terms and definitions
121 4 Symbols and abbreviated terms
124 5 Description of the information modelling principles and practices
5.1 General considerations
5.2 Conceptual overview diagrams
125 5.3 Section high-level diagrams
5.4 Detailed diagrams
126 5.5 Relationships between classes
128 5.6 Notes
5.7 Attributes
5.8 Message exchange format
129 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
131 6.3 Concepts required for the description of specified substances
133 6.3.1 Relationship between Substances and Specified Substance Groups
134 6.4 Naming of substances
135 6.5 Requirements for unique identifiers
6.6 Existing identifiers and molecular structure representation
136 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
137 7.2.3 Modification
138 7.2.4 Reference information
139 7.2.5 Source material
140 7.2.6 Taxonomy
7.2.7 Authentication of Herbal Drugs
141 7.2.8 Substance codes
7.3 Chemical substances
142 7.4 Protein substances
144 7.5 Nucleic acid substances
145 7.6 Polymer substances
146 7.7 Structurally diverse substances
149 7.8 Mixture
150 8 Defining specified substances
8.1 General
151 8.2 Specified Substance Group 1
154 8.3 Specified Substance Group 2
156 8.4 Specified Substance Group 3
157 8.5 Specified Substance Group 4
8.5.1 General
8.5.2 Specified Substance Group 4 Name
158 8.5.3 Grade
8.5.4 Use of analytical data
159 8.5.5 Manufacturing
8.5.6 Version and specification
163 Annex A (informative) Existing identifiers and molecular structure representations
167 Bibliography

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BS EN ISO 11238:2018 - TC
$280.87