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Standard [CURRENT]

DIN EN ISO 18113-5:2013-01

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

German title
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
Publication date
2013-01
Original language
German
Pages
17

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Publication date
2013-01
Original language
German
Pages
17
DOI
https://dx.doi.org/10.31030/1923434

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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.

Content
ICS
11.100.10
DOI
https://dx.doi.org/10.31030/1923434
Replacement amendments

This document replaces DIN EN ISO 18113-5:2010-05 .

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