scope:

This part of ISO 5840 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. This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute. This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This part of ISO 5840 excludes valve-in-valve configurations and homografts. This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve substitutes (e.g. sutureless). For these devices, the requirements of both this part of ISO 5840 and ISO 5840:2005 might be relevant and can be considered.