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Standard ÖNORM EN ISO 10993-16 15.1.2018 preview

ÖNORM EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

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STANDARD published on 15.1.2018


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The information about the standard:

Designation standards: ÖNORM EN ISO 10993-16
Publication date standards: 15.1.2018
SKU: NS-806276
The number of pages: 25
Approximate weight : 75 g (0.17 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Biological evaluation of medical devices

Annotation of standard text ÖNORM EN ISO 10993-16 :

Dieses Dokument stellt Grundlagen für Konzeption und Durchführung von toxikokinetischen Untersuchungen, die bei Medizinprodukten von Bedeutung sind, zur Verfügung. Anhang A beschreibt die Überlegungen zur Durchführung toxikokinetischer Untersuchungen zur biologischen Beurteilung von Medizinprodukten.

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