EN
SR EN ISO 10993-5:2009
Evaluarea biologică a dispozitivelor medicale. Partea 5: Teste pentru citotoxicitate in vitro
ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
Status :
In vigoare
Data aprobării : 30.11.2009
Data publicării : 02.12.2009
Număr de pagini : 46
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 10993-5:2003
- Modificat de SR EN ISO 10993-5:2009/A11:2025