Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_7:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 7 (pt 2/2)
Character Range: 271061–271886

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 are minimised, having regard to the nature of the environment in which the device is intended to be used.

7.7  Minimisation of risks associated with nanomaterials
 (1) A medical device must be designed and produced in a way that ensures that any risks associated with the size and the properties of particles which are, or can be, released into a patient's or user's body are minimised.
 (2) In minimising risks, particular attention must be given to the use of nanomaterials.
 (3) Subclause (1) does not apply to particles that come into contact with intact skin only.