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Paragraph 3 General requirements

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

The characteristics and performances referred to in paragraphs 1 and 2 shall not be adversely affected to such a degree that the clinical condition or safety of the patient or of other persons is compromised during the lifetime of the device expected by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.