ResMed must satisfy global regulators that every product is safe and effective for its intended use. One of the requirements in this regard is to demonstrate an appropriate level of biocompatibility for every material to which a patient is exposed. All ResMed machines are thoroughly tested to comply with ISO 10993-1, the international standard for the biological evaluation of medical machines. To this end, the biocompatibility of the polycarbonate in question has been tested and confirmed by ResMed.
ResMed remains confident in the safety of its polycarbonate products for their intended use.