No products
AAMI 16142-2 2017 Edition, January 1, 2017 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
AAMI 17665-1 2006 Edition, January 1, 2006 Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
AAMI 18241 2016 Edition, September 2, 2016 Cardiovascular implants and extracorporeal systems-Cardiopulmonary bypass systems-Venous bubble traps
AAMI 18242 2016 Edition, September 2, 2016 Cardiovascular implants and extracorporeal systems-Centrifugal blood pumps
AAMI 18472 6th Edition, January 1, 2006 Sterilization of health care products—Biological and chemical indicators—Test equipment
AAMI 20857 10th Edition, January 1, 2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI 22442-1 2016 Edition, January 1, 2016 Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management
AAMI 22442-2 2016 Edition, January 1, 2016 Medical devices utilizing animal tissues and their derivatives-Part 2: Controls on sourcing, collection and handling
AAMI 22442-3 7th Edition, January 1, 2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
AAMI 23500 2014 Edition, January 1, 2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
AAMI 25539-1 2017 Edition, January 1, 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
AAMI 25539-2 2012 Edition, January 1, 2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents