DIN EN ISO 5840-3:2013-06

This part of the DIN EN ISO 5840 standard series is applicable to all medical devices intended for implantation in human hearts as a transcatheter heart valve substitute. It deals particularly with aspects of heath protection and product safety. This standard is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices; it is also applicable for packaging and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. This standard outlines an approach for qualifying the design and manufacture of a transcatheter heart valve substitute on the basis of risk management. The selection of appropriate qualification tests and methods shall be derived from the risk assessment. These tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. These tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This standard specifies design specifications and minimum performance criteria for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This standard has been prepared by ISO/TC 150/SC 2 "Cardiovascular implants and extracorporeal systems" (secretariat: ANSI, USA) in collaboration with CEN/TC 285 "Non-active surgical implants" (secretariat: DIN, Germany). The committee responsible for this standard is NA 027-02-17-01 UA "Herz- und Gefäßimplantate" ("Cardiovascular implants") at DIN.