10Medical devices with a measuring function

#### 10 Medical devices with a measuring function (1) A medical device that has a measuring function must be designed and produced in a way that ensures that the device provides accurate, precise and stable measurements within the limits indicated by the manufacturer and having regard to the intended purpose of the device. (2) The measurement, monitoring and display scale of the device must be designed and produced in accordance with ergonomic principles, having regard to the intended purpose of the device. (3) The measurements made by the device must be expressed: (a) in Australian legal units of measurement or be compared to at least one point of reference indicated in Australian legal units of measurement; or (b) if the device measures a physical quantity for which no Australian legal unit of measurement has been prescribed under the National Measurement Act 1960, in units approved in writing by the Secretary for the particular device.