Division 8

Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:

• the risk of physical injury in connection with their physical, including dimensional, features,

• risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,

• risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration,

• risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment,

• F1risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation ^f1 and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure ^f2 ,

• risks which may arise where maintenance and calibration are impossible, including:

  • excessive increase of leakage currents,

  • ageing of the materials used,

  • excess heat generated by the device,

  • decreased accuracy of any measuring or control mechanism.