(1) For these Regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure:

(a)

quantitatively a physiological or anatomical parameter; or

(b)

a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.

(2)

The measurements given by a medical device that has a measuring function:

(a)

must:

(i)

be displayed in Australian legal units of measurement or other units of measurement approved by the Secretary for the particular device; or

(ii)

be compared to at least one point of reference indicated in Australian legal units of measurement or other units of measurement approved by the Secretary for the particular device; and

(b)

must be accurate to enable the device to achieve its intended purpose.