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 18113-4:2009); German version EN ISO 18113-4:2011
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2009); Deutsche Fassung EN ISO 18113-4:2011
Overview
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of in vitro diagnostic reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturers of calibrators and control materials intended for use with in vitro diagnostic medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies 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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
