Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_12:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 2/4)
Character Range: 283828–286722

information with the device that sets out requirements (including requirements about hardware, software, information technology environments and security measures) necessary to operate the device as intended.
 (5) A programmed or programmable medical device, or software that is a medical device, must be designed, produced and maintained with regard to best practice in relation to software, security and engineering to provide cybersecurity of the device, including where appropriate the following:
 (a) protection against unauthorised access, unauthorised influence or unauthorised manipulation;
 (b) minimisation of risks associated with known cybersecurity vulnerabilities (including either or both of remediation of known vulnerabilities and application of compensating controls);
 (c) facilitation of the application of updates, patches, compensating controls and other improvements;
 (d) disclosure of known vulnerabilities in the device or its components and associated mitigations;
 (e) making available sufficient information for a user to make decisions with respect to the safety of applying, or not applying, updates, patches, compensating controls and other improvements.
 (6) The manufacturer of a programmed or programmable medical device, or software that is a medical device, having regard to the intended purpose of the device, the generally acknowledged state of the art and best practice, must ensure that the data that influences the performance of the device is:
 (a) representative; and
 (b) of sufficient quality; and
 (c) maintained to ensure integrity; and
 (d) managed to reduce bias.

12.2  Safety dependent on internal power supply
 (1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an internal power supply for the device.
 (2) The device must be fitted with a means of determining the state of the power supply.

12.3  Safety dependent on external power supply
 (1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an external power supply for the device.
 (2) The device must be fitted with an alarm system that indicates whether a power failure has occurred.

12.4  Medical devices intended to monitor clinical parameters
  A medical device that is intended by the manufacturer to be used to monitor one or more clinical parameters of a patient must be fitted with an appropriate alarm system to warn the user if a situation has developed that could lead to the death of the patient or a severe deterioration in the state of the patient's health.

12.5  Minimisation of risk of electromagnetic fields
  A medical device must be designed and produced in a way that ensures that the risk of an electromagnetic field being created that could impair the operation of other devices or equipment being used