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Therapeutic Goods (Medical Devices) Regulations 2002
4Long‑term safety
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4 Long‑term safety
A medical device must be designed and produced in a way that ensures that if: (a) the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and (b) the device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and (c) the device is regularly maintained and calibrated in accordance with the manufacturer’s instructions; the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected.