Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 13/26)
Character Range: 677631–680403

medicine or biological as being essential for the safe and effective use of the medicine or biological; and
 (c) if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the individual—that is not intended by the manufacturer to be used for the examination of the specimen merely to determine whether the medicine or biological is compatible with the individual.
IVD medical device, or in vitro diagnostic medical device, means a medical device that is:
 (a) a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with another diagnostic product for in vitro use; and
 (b) intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:
 (i) giving information about a physiological or pathological state or a congenital abnormality; or
 (ii) determining safety and compatibility with a potential recipient; or
 (iii) monitoring therapeutic measures; and
 (c) not a product that is:
 (i) intended for general laboratory use; and
 (ii) not manufactured, sold or presented for use as an IVD medical device.
IVD medical device for self‑testing means an IVD medical device intended to be used:
 (a) in the home or similar environment by a lay person; or
 (b) in the collection of a sample by a lay person and, if that sample is tested by another person, the results are returned directly to the person from whom the sample was taken without the direct supervision of a health professional who has formal training in a medical field or discipline to which the self‑testing relates.
joint replacement medical device means an implantable medical device:
 (a) that is intended by the manufacturer to operate (either alone or together with one or more other implantable medical devices) as a replacement (in whole or in part) for the shoulder joint, hip joint or knee joint; and
 (b) that (either alone or together with one or more other implantable medical devices):
 (i) replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
 (ii) provides primary fixation to the bone for the replacement articulating surface; or
 (iii) connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph (i) or (ii) and operates as an intrinsic element of the joint replacement;
but does not include an ancillary medical device.
kind, in relation to a medical device—see section 41BE of the Act.
knee joint means the joint consisting of:
 (a) the articulations between each of the 2 condyles of the femur and the corresponding surface of the