harm severity value expression

IRI: https://spec.industrialontologies.org/ontology/construct/HarmSeverityValueExpression

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/

SubClass Of: value expression

Class Hierarchy

owl:Thing β€Ί bfo:entity β€Ί bfo:continuant β€Ί bfo:generically dependent continuant β€Ί information content entity β€Ί value expression β€Ί harm severity value expression

Definition

value expression that represents the magnitude of possible or actual harm

Examples

  • minor patient injury; moderate bloodstream infection severity; severe hypoxic injury; severity level 2 for product damage; severity level 4 for coil and cryostat damage; severity score 3 on a 5-point scale for anaphylactic state

Adapted From

  • https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_en.pdf

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs to create a set of necessary and sufficient conditions

Formal Axioms

First-Order Logic Axioms

HarmSeverityValueExpression(x) β†’ ValueExpression(x) ∧ βˆƒh (HarmSpecification(h) ∧ continuantPartOfAtAllTimes(x, h))

Semi-Formal Natural Language Axioms

if x is a β€˜harm severity value expression’ then x is a β€˜value expression’ that is β€˜continuant part of at all times’ some β€˜harm specification’

Description Logic

SubClassOf: constr:ValueExpression

SubClassOf: bfo:continuant_part_of_at_all_times some constr:HarmSpecification


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