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

Description

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 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.

Information 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: 02 6232 8644
Phone: 1800 020 653
Fax: 02 6203 1605
Email: info@tga.gov.au