DIN Standards Committee Health Technologies
DIN EN ISO 18113-2
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 2: In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO 18113-2:2022); Deutsche Fassung EN ISO 18113-2:2024
Overview
The DIN EN ISO 18113-2 standard specifies requirements for the provision of information by manufacturers of reagents for in vitro diagnostic tests. In addition, the standard also applies to the provision of information by manufacturers of calibration materials and control materials intended for use with in vitro diagnostic devices. Where applicable, the standards can also be applied to accessories. They apply to labels for outer and immediate containers and to the instructions for 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 systems" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Qualitätsmanagement in medizinischen Laboratorien" ("Quality management in medical laboratories") at DIN Standards Committee Medicine (NAMed) 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
