TDS PDF

Small-bore connectors for liquids and gases in healthcare applications—Part 6- Connectors for neuraxial applications Original standard AAMI CN6-2015 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 80369-6-2016

Guidance on the application of ISO 14971 to artificial intelligence and machine learning Original standard AAMI CR34971-2022 in PDF full version. Additional info + preview on request

Document status: Replaced by St AAMI TIR34971-2023

Basic Introduction to the IEC 60601 Series Original standard AAMI CR500-2019 in PDF full version. Additional info + preview on request

Document status: Active

Appropriate use of public cloud computing for quality systems and medical devices Original standard AAMI CR510-2021 in PDF full version. Additional info + preview on request

Document status: Replaced by

Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing Original standard AAMI CR513-2024 in PDF full version. Additional info + preview on request

Document status: Active

Cybersecurity considerations unique to machine learning–enabled medical devices Original standard AAMI CR515-2025 in PDF full version. Additional info + preview on request

Document status: Active