Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_12:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 4/4)
Character Range: 289015–290750

of the device, does not reach a potentially dangerous temperature.

12.12  Protection against risks associated with administration of energy or substances
 (1) This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient.
 (2) The device must be designed and produced in a way that ensures that:
 (a) the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and
 (b) as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented.
 (3) The device must be fitted with a means of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person.
 (4) The functions of each control and indicator on the device must be clearly specified on the device.
 (5) If the instructions for the operation of the device, or the operating or adjustment parameters for the device, are displayed by means of a visual system incorporated into the device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient.

12.13  Active implantable medical devices
 (1) An active implantable medical device must incorporate, display, emit or exhibit a code or unique characteristic that can be used to identify:
 (a) the type of device; and
 (b) the manufacturer of the device; and
 (c) the year of manufacture of the device.
 (2) The code or unique characteristic must be able to be read without the need for surgery to the person in whom the device is implanted.