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Standards [CURRENT]

DIN EN ISO 19001
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013

Title (German)

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischen Reagenzien für biologische Färbungen (ISO 19001:2013); Deutsche Fassung EN ISO 19001:2013

Overview

This standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology. The requirements for information supplied by the manufacturer specified in this standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

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 2013-07
Original language German
Translation English
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Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

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Fax: +49 30 2601-42404

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