DIN Standards Committee Health Technologies
DIN EN ISO 18113-5
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009); Deutsche Fassung EN ISO 18113-5:2011
Overview
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of instruments for in vitro diagnostic for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used 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 does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; or c) IVD instruments 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
