ČSN EN ISO 10993-3 (855220)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity



STANDARD published on 1.5.2015


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The information about the standard:

Designation standards: ČSN EN ISO 10993-3
Classification mark: 855220
Catalog number: 97404
Publication date standards: 1.5.2015
SKU: NS-586407
The number of pages: 36
Approximate weight : 108 g (0.24 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 10993-3 (855220):

Tato norma specifikuje strategie pro odhad rizika, výběr zkoušek pro identifikaci nebezpečí a řízení rizika z hlediska genotoxicity, karcinogenity a reprodukční a vývojové toxicity při expozici zdravotnickými prostředky. Norma je použitelná v případech, kdy bylo stanoveno, že zdravotnický prostředek je z těchto hledisek třeba hodnotit

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