Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_8:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 8 (pt 2/2)
Character Range: 274480–275556

and sterilised using an appropriate validated method.
 (4) The device must be produced in appropriately controlled conditions.

8.4  Medical devices to be supplied in a non‑sterile state
 (1) A medical device that is intended by the manufacturer to be supplied in a non‑sterile state must be packed in a way that ensures that the device maintains the level of cleanliness stipulated by the manufacturer.
 (2) If the device is intended to be sterilised before it is used, the device must be packed in a way that:
 (a) ensures that the risk of microbial contamination is minimised; and
 (b) is suitable, having regard to the method of sterilisation that the manufacturer indicates is to be used for the device.
 (3) The device must be produced in appropriately controlled conditions.

8.5  Distinction between medical devices supplied in sterile and non‑sterile state
  If a medical device is supplied in both a sterile state and a non‑sterile state, the information provided with the device must clearly indicate whether the device is in a sterile state or a non‑sterile state.