Division 9.2

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

• the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features,

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

• the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,

• risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.