ISO - FDIS 5840-2
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
|Publication Date:||25 June 2020|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2020 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.