EN
SR EN ISO 10993-10:2023
Evaluarea biologică a dispozitivelor medicale. Partea 10: Teste de sensibilizare cutanată
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Status :
In vigoare
Data aprobării : 31.03.2023
Număr de pagini : 63
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 10993-10:2014