TDS PDF

Biological evaluation of medical devices—Part 5- Tests for in vitro cytotoxicity Original standard ANSI AAMI ISO 10993-5-2009 (2022) in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices—Part 6- Tests for local effects after implantation Original standard ANSI AAMI ISO 10993-6-2016 in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices—Part 7- Ethylene oxide sterilization residuals Original standard ANSI AAMI ISO 10993-7-2008 (2012) in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices—Part 8- Selection and qualification of reference materials for biological tests Original standard ANSI AAMI ISO 10993-8-2000 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 10993-12-2012

Biological evaluation of medical devices—Part 9- Framework for identification and quantification of potential degradation products Original standard ANSI AAMI ISO 10993-9-2009 (2014) in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization Original standard ANSI AAMI ISO 11134-1993 (2000) in PDF full version. Additional info + preview on request

Document status: Replaced by