ISO DIS 5840-3
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
|Publication Date:||14 January 2019|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This part of ISO 5840 is applicable to all devices intended for implantation as a transcatheter heart valve substitute (see Annex A for examples).
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 outlines an approach for verifying/validating
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 includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).