You may require this code if you intend to manufacture or supply cardiac valve prostheses.
This standard has been superseded and is referred to in the Catalogue of Australian Standards as ISO 5840:2005 Cardiovascular Implants - Cardiac Valve Prostheses. This standard provides requirements for the design and manufacture of a heart valve substitute. It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
Please note that the Agency has advised that there are various codes for medicines, medical devices and chemicals that are amended on a regular basis. Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required