Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_11:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 11 (pt 1/2)
Character Range: 278205–280971

11  Protection against radiation

11.1  Minimisation of exposure to radiation
  A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised, having regard to the levels of radiation required to enable the device to perform its therapeutic and diagnostic functions and the intended purpose of the device.

11.2  Medical devices intended to emit radiation
 (1) This clause applies in relation to a medical device that is intended by the manufacturer to emit hazardous levels of visible or invisible radiation because the emission is necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent in the emission.
 (2) The device must be designed and produced in a way that ensures that the user can control the level of the emission.
 (3) The device must be designed and produced in a way that ensures the reproducibility and tolerance of relevant variable parameters.
 (4) If practicable, the device must be fitted with a visual indicator or an audible warning, or both, that operates if potentially hazardous levels of radiation are emitted.

11.3  Minimisation of exposure to unintended radiation
  A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to the emission of unintended, stray or scattered radiation is minimised.

11.4  Operating instructions
  The operating instructions for a medical device that emits radiation must include detailed information about the following matters:
 (a) the nature of the radiation emitted;
 (b) the means by which patients and users can be protected from the radiation;
 (c) ways to avoid misusing the device;
 (d) ways to eliminate any risks inherent in the installation of the device.

11.5  Medical devices intended to emit ionising radiation—additional requirements
 (1) This clause applies, in addition to clauses 11.1 to 11.4, in relation to a medical device that is intended by the manufacturer to emit ionising radiation.
 (2) The device must be designed and produced in a way that ensures that, if practicable, the quantity, geometry and energy distribution (or quality) of radiation emitted can be controlled and varied, having regard to the intended purpose of the device.
 (3) If the device is intended to be used for diagnostic radiology, the device must be designed and produced in a way that ensures that, when used in relation to a patient for a purpose intended by the manufacturer:
 (a) the device achieves an appropriate image or output quality for that purpose; and
 (b) the exposure of the patient, or the user, to radiation is minimised.
 (4) If the device is intended to be used