Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_7:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 7 (pt 1/2)
Character Range: 268580–271315

7  Chemical, physical and biological properties

7.1  Choice of materials
  In ensuring that the requirements of Part 1 are met in relation to a medical device, particular attention must be given to:
 (a) the chemical and physical properties of the materials used in the device; and
 (b) the compatibility between the materials used and biological tissues, cells, body fluids and specimens;
having regard to the intended purpose of the device.

7.2  Minimisation of risks associated with contaminants and residues
 (1) A medical device must be designed, produced and packed in a way that ensures that any risks associated with contaminants and residues that may affect a person who is involved in transporting, storing or using the device, or a patient, are minimised, having regard to the intended purpose of the device.
 (2) In minimising risks, particular consideration must be given to the likely duration and frequency of any tissue exposure associated with the transportation, storage or use of the device.

7.3  Ability to be used safely with materials etc
 (1) A medical device must be designed and produced in a way that ensures that the device can be used safely with any material, substance or gas with which the device may come into contact during normal use or use in routine procedures.
 (2) If the device is intended to be used to administer medicine, it must be designed and produced in a way that ensures that the device:
 (a) is compatible with the provisions and restrictions applying to the medicine to be administered; and
 (b) allows the medicine to perform as intended.

7.4  Verification of incorporated substance
 (1) If a medical device incorporates, or is intended to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device:
 (a) the safety and quality of the substance must be verified in accordance with the requirements for medicines; and
 (b) the ancillary action of the substance must be verified having regard to the intended purpose of the device.
 (2) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine.

7.5  Minimisation of risks associated with leaching substances
  A medical device must be designed and produced in a way that ensures that any risks associated with substances that may leach from the device are minimised.

7.6  Minimisation of risks associated with ingress or egress of substances
  A medical device must be designed and produced in a way that ensures that any risks associated with unintentional ingress of substances into, or unintentional egress of substances out of, the device