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Standards [CURRENT]

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

Title (German)

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  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Edition 2013-01
Original language German
Translation English
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Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

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