ISO 5840:1996 Cardiovascular Implants - Cardiac Valve Prostheses - Australian Government

Description

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This standard has been superseded and is referred to in the Catalogue of Australian Standards as ISO 5840:2005 Cardiovascular Implants - Cardiac Valve Prostheses.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

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined 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

Operating 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
Email: info@tga.gov.au