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Standard ČSN EN ISO 10993-17 1.6.2024 preview

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ČSN EN ISO 10993-17 (855220)

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents

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STANDARD published on 1.6.2024


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The information about the standard:

Designation standards: ČSN EN ISO 10993-17
Classification mark: 855220
Catalog number: 519286
Publication date standards: 1.6.2024
SKU: NS-1186256
The number of pages: 68
Approximate weight : 204 g (0.45 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Biological evaluation of medical devices

Annotation of standard text ČSN EN ISO 10993-17 (855220):

Tato norma je rozsáhlou technickou revizí EN ISO 10993-17:2009. Specifikuje proces a požadavky na posuzování toxikologického rizika složek zdravotnických prostředků a metody a kritéria pro posouzení, zda expozice určitou složkou může způsobit poškození pacienta. Posuzování toxikologického rizika je součástí biologického hodnocení výrobku, jak je popsáno v souboru norem EN ISO 10993

Preview of the standard ČSN EN ISO 10993-17 (855220)

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