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Standard [CURRENT]

DIN EN ISO 18113-1:2013-01

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

German title
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
Publication date
2013-01
Original language
German
Pages
60

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Publication date
2013-01
Original language
German
Pages
60
DOI
https://dx.doi.org/10.31030/1923435

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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.

Content
ICS
11.100.10
DOI
https://dx.doi.org/10.31030/1923435
Replacement amendments

This document replaces DIN EN ISO 18113-1:2010-05 .

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