Therapeutic Goods Order No.50 General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods - Australian Government


You may be required to comply with this standard if you intend to import or manufacture therapeutic devices with pyrogen and endotoxin content. Therapeutic devices to which this standard applies include all sterile therapeutic devices which are intended for contact, directly or indirectly, with the cardiovascular system, the lymphatic system or the cerebrospinal fluid and nervous system.

Please note that the Agency has advised that the schedule specifying what therapeutic devices are included corresponds with current international opinion and requirements. It is subject to ongoing review and may be amended from time to time.

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

Regulation(s) name

Therapeutic Goods Regulations 1990 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:

Information Officer

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Phone: 02 6232 8644
Fax: 02 6203 1605
Website: Therapeutic Goods Administration (Opens in new window)