TDS PDF

Packaging for terminally sterilized medical devices—Part 2- Validation requirements for forming, sealing and assembly processes—Amendment 1- Application of risk management Original standard ANSI AAMI ISO 11607-2-2019 A1-2023 in PDF full version. Additional info + preview on request

Document status: Active

Cardiovascular implants and extracorporeal systems—Blood tissue contact surface modifications for extracorporeal perfusion systems Original standard ANSI AAMI ISO 11658-2012 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Microbiological methods—Part 1- Determination of a population of microorganisms on products Original standard ANSI AAMI ISO 11737-1-2018 in PDF full version. Additional info + preview on request

Document status: Active

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Document status: Withdrawn