TDS PDF

Sterilization of medical devices—Microbiological methods—Part 2- Tests of sterility performed in the definition, validation and maintenance of a sterilization process Original standard ANSI AAMI ISO 11737-2-2019 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of medical devices—Microbiological methods—Part 3- Guidance on evaluation and interpretation of bioburden data Original standard ANSI AAMI ISO 11737-3-2004 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 11737-1-2018

Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products—Part 1- General requirements Original standard ANSI AAMI ISO 12417-1-2015 in PDF full version. Additional info + preview on request

Document status: Withdrawn

Sterilization of health care products—Radiation—Substantiation of selected sterilization dose- Method VDmaxSD Original standard ANSI AAMI ISO 13004-2022 in PDF full version. Additional info + preview on request

Document status: Active

Medical products containing viable human cells—Application of risk management and requirements for processing practices Original standard ANSI AAMI ISO 13022-2012 in PDF full version. Additional info + preview on request

Document status: Active

Aseptic processing of health care products—Part 1- General requirements—Amendment 1 Original standard ANSI AAMI ISO 13408-1-2008 (2011) A1-2013 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 13408-1-2023