TDS PDF

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

Sterilization of health care products—Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices Original standard ANSI AAMI ISO 11135-2014 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Radiation—Part 1- Requirements for development, validation, and routine control of a sterilization process for medical devices Original standard ANSI AAMI ISO 11137-1-2006 (2015) + A1-2013 + A2-2019 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Radiation—Part 2- Establishing the sterilization dose Original standard ANSI AAMI ISO 11137-2-2013 (2019) in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Radiation—Part 3- Guidance on dosimetric aspects of development, validation and routine control Original standard ANSI AAMI ISO 11137-3-2017 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 11137-3-2017 (2023)