มอก. 2395 เล่ม 9-2565

Scope (English)

This standard establishes general principles for the systematic assessment of the potential and the resulting degradation of medical devices through the design and performance of in vitro degradation studies. The data obtained from these studies can be used in the biological assessments described in the ISO 10993 series. This standard is suitable for use with both materials designed to biodegrade in the body and materials that are not intended to decompose.