TDS PDF

Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose- Method VDmaxSD Original standard ANSI AAMI ISO TIR13004-2013 (2016) in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 13004-2022

Medical devices—Quality management systems—Guidance on the application of ISO 13485-2003 Original standard ANSI AAMI ISO TIR14969-2004 in PDF full version. Additional info + preview on request

Document status: Withdrawn

Sterilization of health care products—Radiation sterilization—Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits Original standard ANSI AAMI ISO TIR15843-2000 in PDF full version. Additional info + preview on request

Document status: Replaced by

Sterilization of health care products—Moist Heat—Part 2- Guidance on the application of ANSI AAMI ISO 17665-1 Original standard ANSI AAMI ISO TIR17665-2-2009 (2016) in PDF full version. Additional info + preview on request

Document status: Active

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass Original standard ANSI AAMI ISO TIR19024-2016 in PDF full version. Additional info + preview on request

Document status: Active

Medical devices—Hierarchal coding structure for adverse events—Part 1- Event-type codes Original standard ANSI AAMI ISO TIR19218-1-2011 + A1-2013 in PDF full version. Additional info + preview on request

Document status: Withdrawn