You will be required to comply with this standard if you intend to manufacture or supply cardiac valve prostheses.
This standard outlines the design and manufacture standards of a surgical heart valve substitute intended for implantation in human hearts. This standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices and also excludes homografts.
Please note that the Agency has advised that there are various standards for medicines, medical devices and chemicals that are amended on a regular basis.
Note that this standard has been updated and you will need to meet the requirements set out in ISO 5840-2:2021 Cardiovascular Implants - Cardiac Valve Prostheses - Part 2: Surgically Implanted Heart Valve Substitutes.
