DIN Standards Committee Health Technologies
DIN EN ISO 18113-4
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022); German version EN ISO 18113-4:2024
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2022); Deutsche Fassung EN ISO 18113-4:2024
Overview
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of in vitro diagnostic tests for self-testing. This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This part of ISO 18113 can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use. 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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
