TDS PDF

Packaging for terminally sterilized medical devices—Part 1- Requirements for materials, sterile barrier systems and packaging systems. Amendment 1- Application of risk management Original standard ANSI AAMI ISO 11607-1-2019 A1-2023 in PDF full version. Additional info + preview on request

Document status: Active

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

Document status: Active

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

Quality of dialysis fluid for hemodialysis and related therapies Original standard ANSI AAMI ISO 11663-2009 in PDF full version. Additional info + preview on request

Document status: Replaced by

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