TDS PDF

Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2- General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards Original standard ANSI AAMI ISO 16142-2-2017 in PDF full version. Additional info + preview on request

Document status: Active

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices Original standard ANSI AAMI ISO 17664-2017 in PDF full version. Additional info + preview on request

Document status: Replaced by

Sterilization of health care products—Moist heat—Part 1- Requirements for the development, validation, and routine control of a sterilization process for medical devices Original standard ANSI AAMI ISO 17665-1-2006 (2013) in PDF full version. Additional info + preview on request

Document status: Active

Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps Original standard ANSI AAMI ISO 18241-2016 in PDF full version. Additional info + preview on request

Document status: Active

Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps Original standard ANSI AAMI ISO 18242-2016 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Biological and chemical indicators—Test equipment Original standard ANSI AAMI ISO 18472-2006 (2015) in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 18472-2022