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BS EN ISO 11616:2017 – TC:2020 Edition

BS EN ISO 11616:2017 – TC:2020 Edition

$217.84

Tracked Changes. Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

Published By Publication Date Number of Pages
BSI 2020 0
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PDF Catalog

PDF Pages PDF Title
71 undefined
73 European foreword
Endorsement notice
76 Foreword
77 Introduction
79 1 Scope
2 Normative references
80 3 Terms, definitions and abbreviated terms
87 4 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
5 Requirements
5.1 Elements required for the unique identification of pharmaceutical products
88 5.2 Exchange of pharmaceutical product information
6 Description of the information modelling principles and practices
6.1 General considerations
89 6.2 Conceptual overview diagrams
6.3 High-level diagrams
90 6.4 Detailed description diagrams
6.4.1 General
91 6.4.2 Relationships between classes
92 6.4.3 Attributes of classes
6.4.4 Generalised classes and patterns
6.4.5 Translation and language
7 Identifying characteristics for the identification of pharmaceutical products
7.1 Pharmaceutical product identification strata and levels
7.1.1 General
93 7.1.2 PhPID specified substance
94 7.1.3 Pharmaceutical product specified substance identification (PhPID SpSub)
95 7.2 Cardinality
7.3 Representation of strength concentration
96 7.4 Pharmaceutical product identifier (PhPID)
7.5 Pharmaceutical product substance stratum elements (PhPID_SUB_Lx)
7.5.1 Construct of the pharmaceutical product substance stratum
7.5.2 Substance set
97 7.5.3 Administrable dose form
7.5.4 Unit of presentation
7.5.5 Medical device
7.6 Pharmaceutical product specified substance stratum elements (PhPID_SpSUB_Lx)
7.6.1 Construct of the pharmaceutical product specified substance stratum
98 7.6.2 Specified substance set
7.6.3 Administrable dose form
7.6.4 Unit of presentation
7.6.5 Medical device
7.7 Identifying characteristics to express strength
7.7.1 Expressing strength
99 7.7.2 Attributes for representation of strength in PhPID stratum elements
101 7.7.3 Representation of strength for a patch
8 Relationship between MPID/PCID and PhPID
8.1 Concepts required for the unique identification of a Medicinal Product and the association with PhPIDs
103 8.2 Pharmaceutical product identification criteria
8.2.1 General considerations
8.2.2 Multiple products packaged as a kit and administered as separate Medicinal Products
104 8.2.3 Multiple products packaged as a kit for reconstitution and administered as one Medicinal Product
8.2.4 Components of kits which are not packaged together (e.g. radiopharmaceutical kits)
8.2.5 Different representations of strength in two or more regions for identical products
105 8.2.6 Representation of PhPID for a patch
9 Relationship between IMPID/IPCID and PhPID
107 10 Conceptual model
108 Bibliography

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BS EN ISO 11616:2017 - TC
$217.84