ČSN EN ISO 10993-16 (855220)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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STANDARD published on 1.4.2018


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The information about the standard:

Designation standards: ČSN EN ISO 10993-16
Classification mark: 855220
Catalog number: 504701
Publication date standards: 1.4.2018
SKU: NS-811178
The number of pages: 20
Approximate weight : 60 g (0.13 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

Biological evaluation of medical devices

Annotation of standard text ČSN EN ISO 10993-16 (855220):

Tato norma uvádí zásady pro navrhování a provádění toxikokinetických studií relevantních pro zdravotnické prostředky a popisuje, za jakých okolností musí být zvažováno provedení toxikokinetických studií v rámci biologického hodnocení zdravotnických prostředků

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