BS EN ISO 18113-1:2024 - TC

This standard BS EN ISO 18113-1:2024 - TC Tracked Changes. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations. This document does not apply to: a) IVD medical devices for performance evaluation (e.g. for investigational use only); b) shipping documents; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements). .