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 18113-2:2009); German version EN ISO 18113-2:2011
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 2: In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO 18113-2:2009); Deutsche Fassung EN ISO 18113-2:2011
Overview
The standards DIN EN ISO 18113-2 and DIN EN ISO 18113-4 specify requirements for information supplied by the manufacturer of in vitro diagnostic reagents for professional use (Part 2) or for self-testing (Part 4). Furthermore the standards also apply for information supplied by the manufacturer of calibrators and control materials intended for use with IVD medical devices for professional use or self-testing. The standards can also be applied to accessories. They apply to labels for outer and immediate containers and to the instructions for use.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
