Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_9
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 9
Character Range: 275558–277250

9  Construction and environmental properties

9.1  Medical devices intended to be used in combination with other devices or equipment
  A medical device that is intended by the manufacturer to be used in combination with another medical device or other equipment (including a connection system) must be designed and produced in a way that ensures that:
 (a) the medical device, and any other device or equipment with which it is used, operate in a safe way; and
 (b) the intended performance of the device, and any other device or equipment with which it is used, is not impaired.

9.2  Minimisation of risks associated with use of medical devices
  A medical device must be designed and produced in a way that ensures that, as far as practicable, the following risks are removed or minimised:
 (a) the risk of injury arising from the physical features of the device;
 (b) any risks associated with reasonably foreseeable environmental conditions;
 (c) the risk of reciprocal interference involving other devices that are normally used in an investigation or treatment of the kind for which the device is intended to be used;
 (d) any risks arising if maintenance or calibration of the device is not possible;
 (e) any risks associated with the ageing of materials used in the device;
 (f) any risks associated with loss of accuracy of any measuring or control mechanism of the device;
 (g) the risk of fire or explosion occurring during normal use of the device, and in the event of a single fault condition, especially if the device is intended to be exposed to flammable substances or substances that can cause combustion;
 (h) the risks associated with disposal of any waste substances.