SNV - SN EN ISO 5840-3
Cardiovascular implants - Cardiac valve prostheses
|Publication Date:||1 October 2009|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This part of ISO 5840 outlines an approach for
This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence 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 substitute 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.
NOTE A rationale for the provisions of this part of ISO 5840 IS given in Annex A.
The manufacturer shall determine, at all stages of the product life cycle, the acceptability of the product for clinical use.