Project

In vitro diagnostic medical devices - Performance evaluation - Requirements and guidance

Begin

2026-07-08

WI

00140174

Planned document number

DIN EN ISO 26358

Project number

17600248

Responsible national committee

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

Responsible european committee

CEN/TC 140/WG 11 - Annex Z in CEN/TC 140  

Responsible international committee

ISO/TC 212/WG 3 - In vitro diagnostic products  

previous edition(s)

Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
2002-08

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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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