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

Description

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

This code outlines the design and manufacture standards of a surgical heart valve substitute intended for implantation in human hearts. 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 Australian Government

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.

Please use these contact details for help or more information:

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)