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.