MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build

MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions

Notation

This page should provide some introductory explanations on how to use the information that is shown on this site.

How to read the drawings/diagrams?

This page is intended to explain the notation being used in the different models. It should help to read and understand the models, especially the class diagrams:

NotationNotationAbstract ClassgeneralAttributeClass 1specialAttributeForClass1Class 2specialAttributeForClass2related ClasscompositedClassaggregatedClassrelated to relationshipattributes for this specific relationshipto abstracta..bm..n

Explanation:

  • all boxes represent classes
  • "Abstract Class" is an abstract class that cannot be instantiated. (It is written in italics.)
  • "Class 1" and "Class 2" are specialisations of the "Abstract Class" which is documented by the arrow.
    • both can be instantiated because they are not abstract.
  • "generalAttribute" is an attribute in the abstract class, that is inherited to the specialisations. All specialisations have this attribute.
  • "specialAttributeForClassX" is an attribute that is valid in this class, and perhaps inherited to further specialised classes that are not shown here.
  • "related Class" is a class that is somehow related to "Abstract Class", i.e. with the class to which the connection goes.
    • "to abstract" (with the small arrow on the left) denotes the direction of the connection/relationship.
    • "a..b" denotes the cardinality of "abstract class" for each element of "related class" element. For example, each "related class" instance can have "a" to "b" related "abstract class" instances.
    • "m..n" denotes the cardinality of "related element" for each element of "abstract class".
  • Aggregation ("aggregated class"):
    • It represents a "part of" relationship.
    • this class is part of "related class".
    • Objects of "related class" and this class have separate lifetimes.
  • Composition ("composited class"):
    • A special type of aggregation where parts are destroyed when the whole is destroyed.
    • Objects of this class live and die with "related class".
    • Objects of this class cannot stand by itself.
  • Classes can be grouped together to help with reading.
  • the "related to relationship" class is a set of information the belongs to the relationship between the two associated classes

How to provide the requirements/evidences?

The Excel sheet is organized into different columns that are explained following:

The first 3 rows are extracted from the original standards document.

chapter page paragraph/section
extracted from paragraph extracted from paragraph content taken from document

The next 5 rows are used to add the evidences/requirements in detail. Example:

A label can have the packaging information as a compoent.

source conformance relationship cardinality target
label MAY hasComponent 0..1 packingInfo

Or:

The product is identified by either a product code or a catalog number.

source conformance relatioship cardinality target
  (      
product SHALL identifiedBy 0..1 productCode
  OR      
product SHALL identifiedBy 0..1 catalogNumber
  )