Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 9/26)
Character Range: 667351–670076

and approved by the Secretary under the type examination procedures.
Australian legal unit of measurement has the meaning given by the National Measurement Act 1960.
authorised person—see regulation 10.1.
body orifice:
 (a) means a natural opening, or a permanent artificial opening, in a human being's body; and
 (b) includes the external surface of a human being's eyeball.
central circulatory system means the system in a human being comprising the following vessels:
 (a) arteriae pulmonales;
 (b) aorta ascendens;
 (c) arteriae coronariae;
 (d) arteria carotis communis;
 (e) arteria carotis externa;
 (f) arteria carotis interna;
 (g) arteriae cerebrales;
 (h) trucus brachicephalicus;
 (i) venae cordis;
 (j) venae pulmonales;
 (k) venae cava superior;
 (l) venae cava inferior;
 (m) arcus aorta;
 (n) thoracica aorta;
 (o) abdominalis aorta;
 (p) arteriae ilica communis.
central nervous system means the system in a human being comprising the brain, meninges and spinal cord.
Class 1 in‑house IVD medical device means an in‑house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 1.
Class 1 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 1.
Class I medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class I.
Class 2 in‑house IVD medical device means an in‑house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 2.
Class 2 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 2.
Class IIa medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class IIa.
Class IIb medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class IIb.
Class 3 in‑house IVD medical device means an in‑house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 3.
Class 3 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 3.
Class III medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class III.
Class 4 in‑house IVD medical device means an in‑house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 4.
Class 4 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 4.
classification means a medical device classification.
classification rules, in relation to a medical device, means the rules for classifying the device set out in Schedule 2.
client of an Australian conformity assessment body means a manufacturer with whom the body has an agreement under