ČSN EN ISO 14155 (854001)

Clinical investigation of medical devices for human subjects - Good clinical practice

Translate name

STANDARD published on 1.1.2021


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The information about the standard:

Designation standards: ČSN EN ISO 14155
Classification mark: 854001
Catalog number: 511622
Publication date standards: 1.1.2021
SKU: NS-1012672
The number of pages: 84
Approximate weight : 283 g (0.62 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 14155 (854001):

Tato norma specifikuje správnou klinickou praxí při navrhování, provádění a zaznamenávání průběhu klinické zkoušky, a podávání zpráv o klinické zkoušce prováděné na lidských subjektech za účelem posouzení klinické funkčnosti nebo účinnosti a bezpečnosti zdravotnických prostředků

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