S.L. 427.16 Art. 4and 3 of this or the safety compromised the device is use. When no expected of a use of

The characteristics and performances referred to in points 1 section must not be adversely affected to such a degree that the health of the patient or the user and, where applicable, of other persons, are during the lifetime of the device as indicated by the manufacturer, when subjected to the stresses which can occur during normal conditions of lifetime is stated, the same applies for the lifetime reasonably to be device of that kind, having regard to the intended purpose and the anticipated the device.