DIN EN ISO 18113-1
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009); Deutsche Fassung EN ISO 18113-1:2011
Overview
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic medical devices. This part of ISO 18113 does not address specifications for language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to: a) in vitro diagnostic medical devices for performance evaluation (for instance for investigational use only), b) instrument marking, c) material safety data sheets.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
