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Standard ÖNORM EN 13975 1.11.2003 preview

ÖNORM EN 13975

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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STANDARD published on 1.11.2003


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The information about the standard:

Designation standards: ÖNORM EN 13975
Publication date standards: 1.11.2003
SKU: NS-759061
The number of pages: 18
Approximate weight : 54 g (0.12 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 13975 :

Diese ÖNORM legt Anforderungen an Probenahmeverfahren für die Prüfungen fest, durch welche die Homogennität von Prozessen und Produkten nachgewiesen und kontrolliert wird. Diese ÖNORM gilt auch für die Erstellung von Stichprobenplänen für Fertigprodukte nach den Bestimmungen für Produktzertifizierungsprogramme und Qualitätsmanagementsysteme des Herstellers.

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