ISO 5840:2:2015 - Cardiovascular Implants - Cardiac Valve Prostheses - Part 2: Sugically Implanted Heart Valve Substitues - Australian Government


You may require this code if you intend to manufacture or supply cardiac valve prostheses.

This code outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management.This code excludes heart valve substitutes designed for implantation in artificial hearths or heart assist devices and also excludes homografts.

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

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Enquiries Officer

Therapeutic Goods Administration

Department of Health

Mailing address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 1800 020 653
Phone: 02 6232 8644