Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_8:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 8 (pt 1/2)
Character Range: 271888–274740

8  Infection and microbial contamination

8.1  Minimisation of risk of infection and contamination
 (1) A medical device must be designed and produced in a way that ensures that the risk of infection to a patient, a user, or any other person, is eliminated or minimised.
 (2) The device must be designed in a way that:
 (a) allows it to be easily handled; and
 (b) if appropriate, minimises contamination of the device or specimen by the patient, user or other person; and
 (c) if appropriate, minimises contamination of the patient, user or other person by the device or specimen.

8.2  Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances
 (1) This clause applies in relation to a medical device that contains:
 (a) tissues, tissue derivatives, cells or substances of animal origin that have been rendered non‑viable; and
 (b) tissues, tissue derivatives, cells or substances of microbial or recombinant origin.
 (2) If the tissues, tissue derivatives, cells or substances originated from animals, the animals must have been subjected to appropriate veterinary controls and supervision, having regard to the intended use of the tissues, tissue derivatives, cells or substances.
 (3) If the medical device contains tissues, tissue derivatives, cells or substances of animal origin, a record must be kept of the country of origin of each animal from which the tissues, tissue derivatives, cells or substances originated.
 (4) The processing, preservation, testing and handling of tissues, tissue derivatives, cells or substances of animal, microbial or recombinant origin must be carried out in a way that ensures the highest standards of safety for a patient, the user of the device, and any other person.
 (5) In particular, the production process must implement validated methods of elimination, or inactivation, in relation to viruses and other transmissible agents.
Note: This may not apply to certain IVD medical devices if the characteristics mentioned in subclause 8.2(5) are integral to the intended purpose of the IVD medical device.

8.3  Medical devices to be supplied in a sterile state
 (1) This clause applies in relation to a medical device that is intended by the manufacturer to be supplied in a sterile state.
 (2) The device must be designed, produced and packed in a way that ensures that the device is sterile when it is supplied, and will remain sterile, if stored and transported in accordance with the directions of the manufacturer, until the protective packaging is opened or damaged.
 (3) The device must be produced 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