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Standard ÖNORM EN 13612 1.8.2002 preview

ÖNORM EN 13612

Performance evaluation of in vitro diagnostic medical devices

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STANDARD published on 1.8.2002


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The information about the standard:

Designation standards: ÖNORM EN 13612
Publication date standards: 1.8.2002
SKU: NS-758282
The number of pages: 15
Approximate weight : 45 g (0.10 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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The category - similar standards:

In vitro diagnostic test systems

Annotation of standard text ÖNORM EN 13612 :

Diese Norm gilt für die Leistungsbewertung von In-vitro-Diagnostika, einschließlich solcher zur Eigenanwendung. Sie legt die Verantwortlichkeiten und allgemeinen Erfordernisse zur Planung, Durchführung, Auswertung und Dokumentation einer Leistungsbewertungsstudie durch den Hersteller fest.

These changes apply to this standard:

Preview ÖNORM EN 13612/AC 1.9.2003
ÖNORM EN 13612/AC Change

Performance evaluation of in vitro diagnostic medical devices (Corrigendum of English version)

Change published on 1.9.2003

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Latest update: 2026-04-23 (Number of items: 2 274 600)
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