DIN EN ISO 18113-1:2024-10

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 ISO 18113 does not address language requirements since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to: a) IVD medical devices for performance evaluation (for example, for investigational use only); b) shipping documents; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements). This document has been prepared by Technical Committee ISO/TC 212 " Medical laboratories and in vitro diagnostic systems" in collaboration with Technical Committee CEN/TC 140 "In vitro diagnostic medical devices" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Quality management in medical laboratories" at DIN Standards Committee Health Technologies (NAGesuTech) is responsible for this standard.