TDS PDF

Fluid delivery performance testing for infusion pumps Original standard AAMI TIR101-2021 in PDF full version. Additional info + preview on request

Document status: Replaced by

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485-2016 Quality Management Systems Original standard AAMI TIR102-2019 in PDF full version. Additional info + preview on request

Document status: Active

Guidance on transferring health care products between radiation sterilization sources Original standard AAMI TIR104-2022 in PDF full version. Additional info + preview on request

Document status: Active

Risk management guidance for combination products Original standard AAMI TIR105-2020 in PDF full version. Additional info + preview on request

Document status: Active

Microbiological methods—Understanding and use of product bioburden data Original standard AAMI TIR106-2024 in PDF full version. Additional info + preview on request

Document status: Active

Cardiovascular implantable electronic devices—Battery longevity management and reporting and prolonged service period behavior Original standard AAMI TIR107-2026 in PDF full version. Additional info + preview on request

Document status: Active