SR EN ISO 10993-10:2011

Evaluarea biologică a dispozitivelor medicale. Partea 10: Teste de iritare şi de sensibilizare cutanată

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes: pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

Adaugă în coș

Informații generale

Status : Anulat
Data aprobării : 31.01.2011
Data anulării : 31.01.2014
Număr de pagini : 80
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale

Relaţii cu alte standarde:

Inlocuieste SR EN ISO 10993-10:2009
Inlocuit prin SR EN ISO 10993-10:2014