Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_12:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 1/4)
Character Range: 281253–284124

12  Medical devices connected to or equipped with an energy source

12.1  Programmed or programmable medical device or software that is a medical device
 (1) A programmed or programmable medical device, or software that is a medical device, that is intended to make use of either or both of data and information must be designed and produced in a way that ensures that:
 (a) the safety, performance, reliability, accuracy, precision, useability, security and repeatability of the device are appropriate for the intended purpose of the device; and
 (b) any consequent risks, or impairment of performance, associated with one or more fault conditions is eliminated or appropriately reduced; and
 (c) the device is resilient with respect to interactions that could occur during the use of the device and that could result in unsafe performance of the device; and
 (d) if relevant to the safety of a patient, or the safety and health of the user or any other person, the device provides suitable warnings in a timely manner:
 (i) following the disruption to services upon which the device is dependent for the device's operation; and
 (ii) following the performance of the device being adversely affected; and
 (e) if relevant to the safety of a patient, or the safety and health of the user or any other person, the device provides a means by which the user can verify correct operation of the device; and
 (f) if relevant to the safety of a patient, or the safety and health of the user or any other person, the integrity and quality of the data or information is maintained; and
 (g) if relevant, the privacy of the data or information is maintained.
 (2) A programmed or programmable medical device, or software that is a medical device, must be developed, produced and maintained having regard to the generally acknowledged state of the art (including for design, development life cycle, development environment, version control, quality and risk management, security, verification and validation, change and configuration management and problem resolution).
 (3) A programmed or programmable medical device, or software that is a medical device, that is intended to be used in combination with computing platforms must be designed and developed taking into account the capability, resources and configuration of the platforms and the external factors (including information technology environments) related to the use of the platforms.
 (4) The manufacturer of a programmed or programmable medical device, or software that is a medical device, must provide instructions or 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,