Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_4
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 267326–267876

4  Long‑term safety
  A medical device must be designed and produced in a way that ensures that if:
 (a) the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and
 (b) the device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and
 (c) the device is regularly maintained and calibrated in accordance with the manufacturer's instructions;
the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected.