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1 Scope This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices . This part of…
Overview EN ISO 18113-1:2024 (identical to ISO 18113-1:2022) is the harmonized European adoption of an international standard that defines terms, concepts and general requirements for information sup…
Overview ISO 18113-1:2022 - "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements" defines the core concep…