DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 18113-3
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009); Deutsche Fassung EN ISO 18113-3:2011
Overview
The revised standard includes a more precise version of Annex ZA, which presents the relationship between the European Standard and the essential requirements of the EU Directive 98/79/EC on in vitro diagnostic medical devices.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories