TDS PDF

Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process Original standard AAMI ISO TIR15499-2017 in PDF full version. Additional info + preview on request

Document status: Active

Radiation sterilization—Selection of a sterilization dose for small or infrequent production batches Original standard AAMI ISO TIR15844-1998 in PDF full version. Additional info + preview on request

Document status: Withdrawn

Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2 Original standard AAMI ISO TIR16775-2014 in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI ISO TIR16775-2023

Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2 Original standard AAMI ISO TIR16775-2023 in PDF full version. Additional info + preview on request

Document status: Active

Cardiovascular implants and extracorporeal systems—Cardiovascular absorbable implants Original standard AAMI ISO TIR17137-2014 in PDF full version. Additional info + preview on request

Document status: Withdrawn

Sterilization of health care products—Moist heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization Original standard AAMI ISO TIR17665-3-2014 (2016) in PDF full version. Additional info + preview on request

Document status: Active