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Draft standard [New]

DIN EN ISO 5649
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023

Title (German)

Medizinische Laboratorien - Konzepte und Spezifikationen für den Entwurf, die Entwicklung, die Herstellung und den Einsatz hauseigener In-vitro-Diagnostika (laborentwickelte Tests) (ISO/DIS 5649:2023); Deutsche und Englische Fassung prEN ISO 5649:2023

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Responsible international committee

ISO/TC 212/WG 1 - Quality and competence in the medical laboratory  

Edition 2024-02
Original language German , English
Price from 129.30 €
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Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

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