This document is applicable to all devices intended for implantation as a transcatheter heart valve
substitute.
This document is applicable to 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 document establishes 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 can
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.
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 2.4 MB |
| ISBN(s) : | 9780539027945 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 66 |
| Product Code(s) : | 30385882, 30385882, 30385882 |
| Published : | 02/08/2021 |
| Same As : | BS EN ISO 5840-3:2021 |
