Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ANSI/AAMI/ISO 5840-3:2013 history
1970ANSI/AAMI/ISO 5840-3:2022 Cardiovascular implants— Cardiac valve prostheses— Part 3: Heart valve substitutes implanted by transcatheter techniques
2012ANSI/AAMI/ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3:Heart valve substitutes implanted by transcatheter techniques
2012ANSI/AAMI/ISO 5840-3:2012 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques