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EVS-EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

General information

Withdrawn from 15.07.2024
Base Documents
ISO 18113-1:2009; EN ISO 18113-1:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.07.2024
Main
02.11.2011
Main
Main
EVS-EN ISO 18113-1:2010
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

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