AAMI/ISO 5840-3:2012

Applies to all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute. Applies to both newly developed and modified versions and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size to be implanted. Outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. Imposes design specifications and minimum performance specifications for minimally invasive implanted heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.