TDS PDF

Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits Original standard AAMI TIR35-2016 (2021) in PDF full version. Additional info + preview on request

Document status: Active

Validation of software for regulated processes Original standard AAMI TIR36-2007 in PDF full version. Additional info + preview on request

Document status: Withdrawn

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products Original standard AAMI TIR37-2013 in PDF full version. Additional info + preview on request

Document status: Active

Medical device safety assurance case guidance Original standard AAMI TIR38-2019 in PDF full version. Additional info + preview on request

Document status: Replaced by

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices Original standard AAMI TIR39-2009 (2017) in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI TIR39-2009 (2022)

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices Original standard AAMI TIR39-2009 (2022) in PDF full version. Additional info + preview on request

Document status: Active