AAMI/ISO 5840-3:2022 PDF

This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document includes considerations for implantation of a transcatheter heart valve substitute inside pre-existing prosthetic device configurations.