TDS PDF

Biological evaluation of medical devices—Part 16- Toxicokinetic study design for degradation products and leachables Original standard ANSI AAMI ISO 10993-16-2020 (2022) in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices—Part 17- Methods for the establishment of allowable limits for leachable substances Original standard ANSI AAMI ISO 10993-17-2002 (2008) in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 10993-17-2002 (2012)

Biological evaluation of medical devices—Part 17- Methods for the establishment of allowable limits for leachable substances Original standard ANSI AAMI ISO 10993-17-2002 (2012) in PDF full version. Additional info + preview on request

Document status: Active

Biological evaluation of medical devices—Part 2- Animal welfare requirements Original standard ANSI AAMI ISO 10993-2-2006 (2010) in PDF full version. Additional info + preview on request

Document status: Replaced by

Biological evaluation of medical devices—Part 3- Tests for genotoxicity, carcinogenicity, and reproductive toxicity Original standard ANSI AAMI ISO 10993-3-2014 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 10993-3-2014 (2023)

Biological evaluation of medical devices—Part 3- Tests for genotoxicity, carcinogenicity, and reproductive toxicity Original standard ANSI AAMI ISO 10993-3-2014 (2023) in PDF full version. Additional info + preview on request

Document status: Active