The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons or the environment are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use."
Pārslodzes, kas ierīces mūžā, kādu tai paredzējis ražotājs, var rasties parastos lietošanas apstākļos, nedrīkst nelabvēlīgi ietekmēt 1. un 2. iedaļā minētos parametrus un darbības tiktāl, lai apdraudētu slimnieku un attiecīgā gadījumā citu cilvēku vai vides veselību un drošību.”