Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
This standard was last reviewed and confirmed* in 2013.
ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.
Document published on: 2009-12 Edition: 2 (Monolingual) ICS: 11.100.20 Status: Published Stage: 90.93 (2013-07-09) TC/SC: ISO/TC 194 Number of Pages: 9
Revised by: ISO/CD 10993-9
Revises: ISO 10993-9:1999
No corrigenda or amendments available