ISO/TS 19844:2015
Health informatics — Identification of medicinal products — Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
ISO/TS 19844:2015 is used in the implementation of ISO 11238. ISO/TS 19844:2015 defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.
ISO 11238 provides the conceptual framework for defining substances and specified substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high level model for the structuring of information for substances. ISO/TS 19844:2015 provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of substances and specified substances.
This first edition of ISO/TS 19844:2015 will only address substances, and Groups 1 to 3 of the specified substances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of ISO/TS 19844:2015. Some information that would typically fall under specified substances Group 4 may be covered in the Annexes of ISO/TS 19844:2015. This information, although not defining of either a substance or a specified substance Group 1, may be essential to distinguishing substances.
ISO/TS 19844:2015 addresses the following:
Data elements necessary for defining substances and specified substances Groups 1 to 3;
The logical use of data elements as defined in ISO 11238;
Substances and specified substances Groups 1 to 3 business rules for
- determining necessary data elements,
- distinguishing and defining materials according to ISO 11238,
- triggering the assignment of identifiers.
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1 Scope
2 Normative references
3 General background and history
4 Substance (Mandatory)
4.1 General
4.2 Defining substances
4.3 Substance types (Mandatory)
4.4 Substance ID (Mandatory)
4.5 Substance names (Mandatory)
4.5.1 Substance name
4.5.2 Substance name type
4.5.3 Language
4.5.4 Official name (repeat as necessary)
4.5.4.1 Official name type
4.5.4.2 Official name status
4.5.4.3 Official name status change date
4.5.4.4 Official name domain (repeat as necessary)
4.5.4.5 Official name jurisdiction (repeat as necessary)
4.6 Reference sources (Mandatory)
4.6.1 Public domain
4.6.2 Reference source type
4.6.3 Reference source class
4.6.4 Reference source ID
4.6.5 Reference source citation
4.6.6 Reference source document (new class to be included in the second edition of ISO 11238)
4.6.7 Reference source document type (new class to be included in the second edition of ISO 11238)
4.6.8 Reference source document classification (new class to be included in the second edition of ISO 11238)
4.6.9 Reference source URL (new class to be included in the second edition of ISO 11238)
4.7 Substance code (Conditional)
4.7.1 Code
4.7.2 Code system
4.7.3 Code system ID
4.7.4 Code system status
4.7.5 Code system status change date
4.7.6 Comment
4.7.7 Reference source
4.7.7.1 Reference information
4.7.8 Substance classification (repeat as necessary)
4.7.8.1 Domain
4.7.8.2 Substance classification (code system)
4.7.8.3 Substance classification type
4.7.8.3.1 Substance classification subtype (repeat as necessary)
4.7.8.3.2 Substance classification code
4.7.8.3.3 Reference source
4.7.9 Target
4.7.9.1 Target ID
4.7.9.2 Target name
4.7.9.3 Interaction type
4.7.9.4 Target organism (new class to be included in the second edition of ISO 11238)
4.7.9.5 Target organism type
4.7.9.6 Target type
4.7.9.6.1 Reference source
4.7.10 Gene
4.7.10.1 Gene sequence origin
4.7.10.2 Gene ID
4.7.10.3 Gene name
4.7.10.3.1 Reference source
4.7.11 Gene elements
4.7.11.1 Gene element type
4.7.11.2 Gene element ID
4.7.11.3 Gene element name
4.7.11.4 Reference source
4.7.12 Substance relationship
4.7.12.1 Relationship
4.7.12.1 Interaction type
4.7.12.2 Related substance ID
4.7.12.3 Related substance name
4.7.12.3.1 Amount type
4.7.12.4 Amount
4.7.12.4.1 Reference source
4.8 Structure (repeat as necessary) (Conditional)
4.8.1 Structural representation type
4.8.2 Structural representation
4.8.3 Structural representation attachment
4.8.4 Stereochemistry
4.8.5 Optical activity
4.8.6 Molecular Formula
4.8.7 Molecular Formula by Moieties (new class to be included in the second edition of ISO 11238)
4.8.8 Isotope (repeat as necessary)
4.8.8.1 Nuclide ID
4.8.8.2 Nuclide name
4.8.8.3 Substitution type
4.9 Amount (Conditional)
4.9.1 Average
4.9.2 Low limit
4.9.3 High limit
4.9.4 Unit
4.9.5 Non-numeric Value
4.10 Source material (Conditional)
4.10.1 Source material class
4.10.2 Source material type
4.10.3 Source material state
4.10.4 Organism ID
4.10.5 Organism name
4.10.6 Development stage
4.10.7 Part description (repeat as necessary)
4.10.7.1 Part
4.10.7.2 Part location
4.10.8 Fraction (repeat as necessary)
4.10.8.1 Material type
4.10.8.2 Fraction
4.10.9 Organism
4.10.9.1 Kingdom
4.10.9.2 Phylum
4.10.9.3 Class
4.10.9.4 Order
4.10.9.5 Family
4.10.9.6 Genus
4.10.9.7 Species
4.10.9.7.1 Species literature reference
4.10.9.7.2 Species parenthetical author
4.10.9.7.3 Species parenthetical author year
4.10.9.7.4 Species primary author
4.10.9.7.5 Species primary author year
4.10.9.7.6 Hybrid species maternal organism ID
4.10.9.7.7 Hybrid species paternal organism ID
4.10.9.7.8 Hybrid type
4.10.9.7.9 Infraspecific type
4.10.9.7.10 Infraspecific description
4.10.9.7.11 Infraspecific literature reference
4.10.9.7.12 Infraspecific parenthetical author
4.10.9.7.13 Infraspecific parenthetical author year
4.10.9.7.14 Infraspecific primary author
4.10.9.7.15 Infraspecific primary author year
4.11 Modification (repeat as necessary) (Conditional)
4.11.1 Modification type
4.11.2 Residue modified
4.11.3 Residue site
4.11.4 Structural modification
4.11.4.1 Structural modification type
4.11.4.1.1 Moiety
4.11.4.1.2 Amount type
4.11.4.1.3 Amount
4.11.4.1.4 Molecular fragment
4.11.4.1.4.1 Fragment role
4.11.4.1.4.2 Molecular fragment ID
4.11.4.1.4.3 Molecular fragment name
4.11.4.1.4.4 Amount type
4.11.4.1.4.4.1 Amount
4.11.4.2 Agent modification
4.11.4.2.1 Agent modification type
4.11.4.2.2 Role
4.11.4.2.3 Modification agent
4.11.4.2.4 Modification agent ID
4.11.4.2.5 Modification process
4.11.4.2.6 Amount type
4.11.4.2.7 Amount
4.11.4.2.8 Role
4.11.4.2.9 Number of parameters
4.11.4.2.9.1.2 Amount type
4.11.4.2.9.1.3 Amount
4.12 Property (Conditional)
4.12.1 Property type
4.12.2 Property name
4.12.3 Property parameters (new class to be included in the second edition of ISO 11238)
4.12.4 Substance name
4.12.5 Substance ID
4.12.6 Amount type
4.12.6.1 Amount
4.13 Version (repeat as necessary) (Mandatory)
4.13.1 Version number
4.13.2 Effective date
4.13.3 Change made
5 Substance definitions
5.1 Chemical substance
5.1.1 Structure
5.1.2 Stoichiometric
5.1.3 Stoichiometric chemicals
5.1.4 Comment
5.1.5 Non-stoichiometric chemicals
5.1.5.1 Number of moieties
5.1.5.2 Moiety (repeat as necessary)
5.1.5.2.1 Moiety role
5.1.5.2.2 Moiety ID
5.1.5.2.3 Moiety name
5.1.5.2.4 Amount type
5.1.5.2.5 Amount
5.1.5.3 Property (repeat as necessary)
5.2 Proteins/peptides
5.2.2 Sequence type
5.2.3 Number of subunits
5.2.4 Disulfide linkage
5.2.5 Comment
5.2.6 Protein subunit (repeat as necessary)
5.2.6.1 Subunit
5.2.6.2 Sequence
5.2.6.3 Length
5.2.6.4 N_Terminal modification
5.2.6.5 N_Terminal modification ID
5.2.6.6 C_Terminal modification
5.2.6.7 C_Terminal modification ID
5.2.7 Molecular weight (repeat as necessary)
5.2.7.1 Molecular weight method
5.2.7.2 Molecular weight type
5.2.7.2.1 Amount
5.2.8 Glycosylation
5.2.8.1 Glycosylation type
5.2.8.2 N-Glycosylation
5.2.8.3 O-Glycosylation
5.2.8.4 C-Glycosylation
5.2.9 Structure
5.2.10 Modification
5.2.11 Property
5.2.11.1 Amount type
5.2.11.1.1 Amount
5.2.12 Molecular weight
5.3 Nucleic acids
5.3.1 Structure
5.3.2 Sequence type
5.3.3 Number of subunits
5.3.4 Area of hybridisation
5.3.5 Comment
5.3.6 Nucleic acid subunit (repeat as necessary)
5.3.6.1 Subunit
5.3.6.2 Sequence
5.3.6.3 Length
5.3.6.4 Sugar (Repeat as necessary) (new classes to be included in the second edition of ISO 11238)
5.3.6.4.1 Residues
5.3.6.4.2 Sugar ID
5.3.6.4.3 Sugar name
5.3.6.5 Linkage group (new classes to be included in the second edition of ISO 11238)
5.3.6.5.1 Linkage
5.3.6.5.2 Linkage name
5.3.6.5.3 Linkage ID
5.3.6.6 Five prime
5.3.6.7 Three prime
5.3.7 Modification
5.3.8 Property
5.3.8.1 Amount type
5.3.8.1.1 Amount
5.3.9 Molecular weight
5.3.9.1 Reference source
5.4 Polymers (to be addressed in more detail in the second edition of this Technical Specification)
5.4.1 Substance name
5.4.2 Structure
5.4.3 Polymer class
5.4.4 Polymer geometry
5.4.5 Copolymer sequence type
5.4.6 Comment
5.4.7 Monomer description (repeat as necessary)
5.4.7.1 Number of monomers
5.4.7.2 Amount type
5.4.7.3 Monomer (repeat as necessary)
5.4.7.3.1 Monomer ID
5.4.7.3.2 Monomer name
5.4.7.3.3 Amount
5.4.8 Structural repeat (repeat as necessary)
5.4.8.1 Number of structural repeat units
5.4.8.2 Amount type
5.4.8.3 Structural repeat unit (repeat as necessary)
5.4.8.3.1 Orientation of polymerisation
5.4.8.3.2 Structural repeat unit
5.4.8.3.3 Amount
5.4.8.3.4 Degree of polymerisation (repeat as necessary)
5.4.9 Molecular weight (repeat as necessary)
5.4.10 Property (repeat as necessary)
5.4.11 Reference source (repeat as necessary)
5.5 Structurally diverse substances
5.5.1 Herbals and substances used in the preparation of plant-based allergenic extracts
5.5.1.1 Naming vegetable oils
5.5.1.1.1 Example: Olive Oil, Virgin
5.5.1.2 Substance type
5.5.1.3 Substance ID
5.5.1.4 Substance name
5.5.1.5 Substance name type
5.5.1.6 Language
5.5.1.7 Official name type
5.5.1.8 Reference sources
5.5.1.8.1 Public domain
5.5.1.8.2 Reference source type
5.5.1.9 Source material
5.5.1.9.1 Source material class
5.5.1.9.2 Source Material Type
5.5.1.9.3 Organism ID
5.5.1.9.4 Organism name
5.5.1.9.5 Development stage
5.5.1.10 Organism (repeat as necessary)
5.5.1.10.1 Kingdom
5.5.1.10.2 Phylum
5.5.1.10.3 Class
5.5.1.10.4 Order
5.5.1.10.5 Family
5.5.1.10.6 Genus
5.5.1.10.7 Species
5.5.1.11 Part description (repeat as necessary)
5.5.1.11.1 Part
5.5.1.11.2 Part location
5.5.1.12 Version (repeat as necessary)
5.5.2 Vaccines - Annex addressing this will be included in the next edition of this Technical Specification
5.5.3 Purified blood products and polyclonal antibodies — an Annex addressing this will be included in the next edition of this Technical Specification
5.5.4 Cells and tissues — an Annex addressing this will be included in the next edition of this Technical Specification
5.5.5 Minerals — an Annex addressing this will be included in the next edition of this Technical Specification
5.6 Mixture substance (repeat as necessary)
5.6.1 Mixture type
5.6.2 Mixture constituent (repeat as necessary)
5.6.2.1 Constituent ID
5.6.2.2 Constituent name
5.6.2.3 Constituent requirement
6 Specified substance (Optional)
6.1 Specified substance Group 1 (repeat as necessary)
6.1.1 Specified substance Group 1 ID
6.1.2 Specified substance Group1 Name
6.1.3 Substance Name (repeat as necessary)
6.1.4 Substance Code
6.1.5 Version (repeat as necessary)
6.1.6 Reference sources
6.1.7 Property (repeat as necessary)
6.1.8 Fraction (new class to be included in the second edition of ISO 11238)
6.1.9 Modification
6.1.10 Reference Information (repeat as necessary)
6.1.11 Constituent (repeat as necessary)
6.1.11.1 Substance ID
6.1.11.2 Substance name
6.1.11.3 Substance role
6.1.11.4 Amount type
6.1.11.4.1 Amount
6.1.12 Physical form (repeat as necessary)
6.1.12.1 Physical state
6.1.12.2 Physical form type
6.1.12.3 Amount type
6.1.12.4 Amount
6.2 Specified substance Group 1 intended for herbal substance and herbal preparation
6.2.1 Specified substance Group 1 ID
6.2.2 Specified substance Group1 Name
6.2.2.1 Substance name (repeat as necessary)
6.2.2.2 Version (repeat as necessary)
6.2.3 Reference sources
6.2.4 Fraction (new class to be included in the second edition of ISO 11238)
6.2.5 Modification (new classes to be included in the second edition of ISO 11238)
6.2.6 Constituent (repeat as necessary)
6.2.6.1 Substance ID
6.2.6.2 Substance name
6.2.6.3 Substance role
6.2.6.4 Amount type
6.2.6.4.1 Amount
6.2.7 Physical form (repeat as necessary)
6.2.7.1 Physical state
6.2.7.2 Physical form type
6.2.7.3 Amount type
6.2.7.3.1 Amount
6.3 Specified substance Group 2 (repeat as necessary)
6.3.1 Specified substance Group2 ID
6.3.2 Specified substance Group2 Name
6.3.3 Parent Substance ID
6.3.4 Manufacturing
6.3.4.1 Manufacturer ID
6.3.4.2 Manufacturer name
6.3.4.3 Manufacturing type
6.3.4.4 Production method type
6.3.4.5 Production system type
6.3.4.6 Production system
6.3.4.7 Critical process version number
6.3.4.8 Substance name (repeat as necessary)
6.3.4.9 Substance Code
6.3.4.10 Reference sources
6.3.4.11 Version (repeat as necessary)
6.4 Specified substance Group 2 for herbal preparations
6.4.1 Specified substance Group2 ID
6.4.2 Specified substance Group2 Name
6.4.3 Parent Substance ID
6.4.4 Manufacturing
6.4.4.1 Manufacturer ID
6.4.4.2 Manufacturer name
6.4.4.3 Manufacturing type
6.4.4.4 Production method type
6.4.5 Version (repeat as necessary)
6.5 Specified substance Group 3 (repeat as necessary)
6.5.1 Specified substance Group 3 ID
6.5.2 Specified substance Group3 Name
6.5.3 Parent Substance ID
6.5.4 Grade
6.5.4.1 Grade type
6.5.4.2 Grade name
6.5.4.3 (Grade) reference source
6.5.5 Reference source (repeat as necessary)
6.5.6 Version (repeat as necessary)
6.5.6.1 (Grade) reference source
6.5.7 Reference source (repeat as necessary)
6.5.8 Version (repeat as necessary)
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1 Scope
2 Normative references
3 General background and history
4 Substance (Mandatory)
4.1 General
4.2 Defining substances
4.3 Substance types (Mandatory)
4.4 Substance ID (Mandatory)
4.5 Substance names (Mandatory)
4.5.1 Substance name
4.5.2 Substance name type
4.5.3 Language
4.5.4 Official name (repeat as necessary)
4.5.4.1 Official name type
4.5.4.2 Official name status
4.5.4.3 Official name status change date
4.5.4.4 Official name domain (repeat as necessary)
4.5.4.5 Official name jurisdiction (repeat as necessary)
4.6 Reference sources (Mandatory)
4.6.1 Public domain
4.6.2 Reference source type
4.6.3 Reference source class
4.6.4 Reference source ID
4.6.5 Reference source citation
4.6.6 Reference source document (new class to be included in the second edition of ISO 11238)
4.6.7 Reference source document type (new class to be included in the second edition of ISO 11238)
4.6.8 Reference source document classification (new class to be included in the second edition of ISO 11238)
4.6.9 Reference source URL (new class to be included in the second edition of ISO 11238)
4.7 Substance code (Conditional)
4.7.1 Code
4.7.2 Code system
4.7.3 Code system ID
4.7.4 Code system status
4.7.5 Code system status change date
4.7.6 Comment
4.7.7 Reference source
4.7.7.1 Reference information
4.7.8 Substance classification (repeat as necessary)
4.7.8.1 Domain
4.7.8.2 Substance classification (code system)
4.7.8.3 Substance classification type
4.7.8.3.1 Substance classification subtype (repeat as necessary)
4.7.8.3.2 Substance classification code
4.7.8.3.3 Reference source
4.7.9 Target
4.7.9.1 Target ID
4.7.9.2 Target name
4.7.9.3 Interaction type
4.7.9.4 Target organism (new class to be included in the second edition of ISO 11238)
4.7.9.5 Target organism type
4.7.9.6 Target type
4.7.9.6.1 Reference source
4.7.10 Gene
4.7.10.1 Gene sequence origin
4.7.10.2 Gene ID
4.7.10.3 Gene name
4.7.10.3.1 Reference source
4.7.11 Gene elements
4.7.11.1 Gene element type
4.7.11.2 Gene element ID
4.7.11.3 Gene element name
4.7.11.4 Reference source
4.7.12 Substance relationship
4.7.12.1 Relationship
4.7.12.1 Interaction type
4.7.12.2 Related substance ID
4.7.12.3 Related substance name
4.7.12.3.1 Amount type
4.7.12.4 Amount
4.7.12.4.1 Reference source
4.8 Structure (repeat as necessary) (Conditional)
4.8.1 Structural representation type
4.8.2 Structural representation
4.8.3 Structural representation attachment
4.8.4 Stereochemistry
4.8.5 Optical activity
4.8.6 Molecular Formula
4.8.7 Molecular Formula by Moieties (new class to be included in the second edition of ISO 11238)
4.8.8 Isotope (repeat as necessary)
4.8.8.1 Nuclide ID
4.8.8.2 Nuclide name
4.8.8.3 Substitution type
4.9 Amount (Conditional)
4.9.1 Average
4.9.2 Low limit
4.9.3 High limit
4.9.4 Unit
4.9.5 Non-numeric Value
4.10 Source material (Conditional)
4.10.1 Source material class
4.10.2 Source material type
4.10.3 Source material state
4.10.4 Organism ID
4.10.5 Organism name
4.10.6 Development stage
4.10.7 Part description (repeat as necessary)
4.10.7.1 Part
4.10.7.2 Part location
4.10.8 Fraction (repeat as necessary)
4.10.8.1 Material type
4.10.8.2 Fraction
4.10.9 Organism
4.10.9.1 Kingdom
4.10.9.2 Phylum
4.10.9.3 Class
4.10.9.4 Order
4.10.9.5 Family
4.10.9.6 Genus
4.10.9.7 Species
4.10.9.7.1 Species literature reference
4.10.9.7.2 Species parenthetical author
4.10.9.7.3 Species parenthetical author year
4.10.9.7.4 Species primary author
4.10.9.7.5 Species primary author year
4.10.9.7.6 Hybrid species maternal organism ID
4.10.9.7.7 Hybrid species paternal organism ID
4.10.9.7.8 Hybrid type
4.10.9.7.9 Infraspecific type
4.10.9.7.10 Infraspecific description
4.10.9.7.11 Infraspecific literature reference
4.10.9.7.12 Infraspecific parenthetical author
4.10.9.7.13 Infraspecific parenthetical author year
4.10.9.7.14 Infraspecific primary author
4.10.9.7.15 Infraspecific primary author year
4.11 Modification (repeat as necessary) (Conditional)
4.11.1 Modification type
4.11.2 Residue modified
4.11.3 Residue site
4.11.4 Structural modification
4.11.4.1 Structural modification type
4.11.4.1.1 Moiety
4.11.4.1.2 Amount type
4.11.4.1.3 Amount
4.11.4.1.4 Molecular fragment
4.11.4.1.4.1 Fragment role
4.11.4.1.4.2 Molecular fragment ID
4.11.4.1.4.3 Molecular fragment name
4.11.4.1.4.4 Amount type
4.11.4.1.4.4.1 Amount
4.11.4.2 Agent modification
4.11.4.2.1 Agent modification type
4.11.4.2.2 Role
4.11.4.2.3 Modification agent
4.11.4.2.4 Modification agent ID
4.11.4.2.5 Modification process
4.11.4.2.6 Amount type
4.11.4.2.7 Amount
4.11.4.2.8 Role
4.11.4.2.9 Number of parameters
4.11.4.2.9.1.2 Amount type
4.11.4.2.9.1.3 Amount
4.12 Property (Conditional)
4.12.1 Property type
4.12.2 Property name
4.12.3 Property parameters (new class to be included in the second edition of ISO 11238)
4.12.4 Substance name
4.12.5 Substance ID
4.12.6 Amount type
4.12.6.1 Amount
4.13 Version (repeat as necessary) (Mandatory)
4.13.1 Version number
4.13.2 Effective date
4.13.3 Change made
5 Substance definitions
5.1 Chemical substance
5.1.1 Structure
5.1.2 Stoichiometric
5.1.3 Stoichiometric chemicals
5.1.4 Comment
5.1.5 Non-stoichiometric chemicals
5.1.5.1 Number of moieties
5.1.5.2 Moiety (repeat as necessary)
5.1.5.2.1 Moiety role
5.1.5.2.2 Moiety ID
5.1.5.2.3 Moiety name
5.1.5.2.4 Amount type
5.1.5.2.5 Amount
5.1.5.3 Property (repeat as necessary)
5.2 Proteins/peptides
5.2.2 Sequence type
5.2.3 Number of subunits
5.2.4 Disulfide linkage
5.2.5 Comment
5.2.6 Protein subunit (repeat as necessary)
5.2.6.1 Subunit
5.2.6.2 Sequence
5.2.6.3 Length
5.2.6.4 N_Terminal modification
5.2.6.5 N_Terminal modification ID
5.2.6.6 C_Terminal modification
5.2.6.7 C_Terminal modification ID
5.2.7 Molecular weight (repeat as necessary)
5.2.7.1 Molecular weight method
5.2.7.2 Molecular weight type
5.2.7.2.1 Amount
5.2.8 Glycosylation
5.2.8.1 Glycosylation type
5.2.8.2 N-Glycosylation
5.2.8.3 O-Glycosylation
5.2.8.4 C-Glycosylation
5.2.9 Structure
5.2.10 Modification
5.2.11 Property
5.2.11.1 Amount type
5.2.11.1.1 Amount
5.2.12 Molecular weight
5.3 Nucleic acids
5.3.1 Structure
5.3.2 Sequence type
5.3.3 Number of subunits
5.3.4 Area of hybridisation
5.3.5 Comment
5.3.6 Nucleic acid subunit (repeat as necessary)
5.3.6.1 Subunit
5.3.6.2 Sequence
5.3.6.3 Length
5.3.6.4 Sugar (Repeat as necessary) (new classes to be included in the second edition of ISO 11238)
5.3.6.4.1 Residues
5.3.6.4.2 Sugar ID
5.3.6.4.3 Sugar name
5.3.6.5 Linkage group (new classes to be included in the second edition of ISO 11238)
5.3.6.5.1 Linkage
5.3.6.5.2 Linkage name
5.3.6.5.3 Linkage ID
5.3.6.6 Five prime
5.3.6.7 Three prime
5.3.7 Modification
5.3.8 Property
5.3.8.1 Amount type
5.3.8.1.1 Amount
5.3.9 Molecular weight
5.3.9.1 Reference source
5.4 Polymers (to be addressed in more detail in the second edition of this Technical Specification)
5.4.1 Substance name
5.4.2 Structure
5.4.3 Polymer class
5.4.4 Polymer geometry
5.4.5 Copolymer sequence type
5.4.6 Comment
5.4.7 Monomer description (repeat as necessary)
5.4.7.1 Number of monomers
5.4.7.2 Amount type
5.4.7.3 Monomer (repeat as necessary)
5.4.7.3.1 Monomer ID
5.4.7.3.2 Monomer name
5.4.7.3.3 Amount
5.4.8 Structural repeat (repeat as necessary)
5.4.8.1 Number of structural repeat units
5.4.8.2 Amount type
5.4.8.3 Structural repeat unit (repeat as necessary)
5.4.8.3.1 Orientation of polymerisation
5.4.8.3.2 Structural repeat unit
5.4.8.3.3 Amount
5.4.8.3.4 Degree of polymerisation (repeat as necessary)
5.4.9 Molecular weight (repeat as necessary)
5.4.10 Property (repeat as necessary)
5.4.11 Reference source (repeat as necessary)
5.5 Structurally diverse substances
5.5.1 Herbals and substances used in the preparation of plant-based allergenic extracts
5.5.1.1 Naming vegetable oils
5.5.1.1.1 Example: Olive Oil, Virgin
5.5.1.2 Substance type
5.5.1.3 Substance ID
5.5.1.4 Substance name
5.5.1.5 Substance name type
5.5.1.6 Language
5.5.1.7 Official name type
5.5.1.8 Reference sources
5.5.1.8.1 Public domain
5.5.1.8.2 Reference source type
5.5.1.9 Source material
5.5.1.9.1 Source material class
5.5.1.9.2 Source Material Type
5.5.1.9.3 Organism ID
5.5.1.9.4 Organism name
5.5.1.9.5 Development stage
5.5.1.10 Organism (repeat as necessary)
5.5.1.10.1 Kingdom
5.5.1.10.2 Phylum
5.5.1.10.3 Class
5.5.1.10.4 Order
5.5.1.10.5 Family
5.5.1.10.6 Genus
5.5.1.10.7 Species
5.5.1.11 Part description (repeat as necessary)
5.5.1.11.1 Part
5.5.1.11.2 Part location
5.5.1.12 Version (repeat as necessary)
5.5.2 Vaccines - Annex addressing this will be included in the next edition of this Technical Specification
5.5.3 Purified blood products and polyclonal antibodies — an Annex addressing this will be included in the next edition of this Technical Specification
5.5.4 Cells and tissues — an Annex addressing this will be included in the next edition of this Technical Specification
5.5.5 Minerals — an Annex addressing this will be included in the next edition of this Technical Specification
5.6 Mixture substance (repeat as necessary)
5.6.1 Mixture type
5.6.2 Mixture constituent (repeat as necessary)
5.6.2.1 Constituent ID
5.6.2.2 Constituent name
5.6.2.3 Constituent requirement
6 Specified substance (Optional)
6.1 Specified substance Group 1 (repeat as necessary)
6.1.1 Specified substance Group 1 ID
6.1.2 Specified substance Group1 Name
6.1.3 Substance Name (repeat as necessary)
6.1.4 Substance Code
6.1.5 Version (repeat as necessary)
6.1.6 Reference sources
6.1.7 Property (repeat as necessary)
6.1.8 Fraction (new class to be included in the second edition of ISO 11238)
6.1.9 Modification
6.1.10 Reference Information (repeat as necessary)
6.1.11 Constituent (repeat as necessary)
6.1.11.1 Substance ID
6.1.11.2 Substance name
6.1.11.3 Substance role
6.1.11.4 Amount type
6.1.11.4.1 Amount
6.1.12 Physical form (repeat as necessary)
6.1.12.1 Physical state
6.1.12.2 Physical form type
6.1.12.3 Amount type
6.1.12.4 Amount
6.2 Specified substance Group 1 intended for herbal substance and herbal preparation
6.2.1 Specified substance Group 1 ID
6.2.2 Specified substance Group1 Name
6.2.2.1 Substance name (repeat as necessary)
6.2.2.2 Version (repeat as necessary)
6.2.3 Reference sources
6.2.4 Fraction (new class to be included in the second edition of ISO 11238)
6.2.5 Modification (new classes to be included in the second edition of ISO 11238)
6.2.6 Constituent (repeat as necessary)
6.2.6.1 Substance ID
6.2.6.2 Substance name
6.2.6.3 Substance role
6.2.6.4 Amount type
6.2.6.4.1 Amount
6.2.7 Physical form (repeat as necessary)
6.2.7.1 Physical state
6.2.7.2 Physical form type
6.2.7.3 Amount type
6.2.7.3.1 Amount
6.3 Specified substance Group 2 (repeat as necessary)
6.3.1 Specified substance Group2 ID
6.3.2 Specified substance Group2 Name
6.3.3 Parent Substance ID
6.3.4 Manufacturing
6.3.4.1 Manufacturer ID
6.3.4.2 Manufacturer name
6.3.4.3 Manufacturing type
6.3.4.4 Production method type
6.3.4.5 Production system type
6.3.4.6 Production system
6.3.4.7 Critical process version number
6.3.4.8 Substance name (repeat as necessary)
6.3.4.9 Substance Code
6.3.4.10 Reference sources
6.3.4.11 Version (repeat as necessary)
6.4 Specified substance Group 2 for herbal preparations
6.4.1 Specified substance Group2 ID
6.4.2 Specified substance Group2 Name
6.4.3 Parent Substance ID
6.4.4 Manufacturing
6.4.4.1 Manufacturer ID
6.4.4.2 Manufacturer name
6.4.4.3 Manufacturing type
6.4.4.4 Production method type
6.4.5 Version (repeat as necessary)
6.5 Specified substance Group 3 (repeat as necessary)
6.5.1 Specified substance Group 3 ID
6.5.2 Specified substance Group3 Name
6.5.3 Parent Substance ID
6.5.4 Grade
6.5.4.1 Grade type
6.5.4.2 Grade name
6.5.4.3 (Grade) reference source
6.5.5 Reference source (repeat as necessary)
6.5.6 Version (repeat as necessary)
6.5.6.1 (Grade) reference source
6.5.7 Reference source (repeat as necessary)
6.5.8 Version (repeat as necessary)
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