Directive 98/79/EC of the European Parliament and of the CouncilShow full title

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

3.3.Devices must be designed and manufactured in such a way as to remove or reduce as far as possible:U.K.
  • the risk of injury linked to their physical features (in particular aspects of volume × pressure, dimension and, where appropriate, ergonomic features),

  • risks linked to reasonably foreseeable external influences, such as magnetic fields, external electrical effects, electrostatic discharge, pressure, humidity, temperature or variations in pressure or acceleration or accidental penetration of substances into the device.

Devices must be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity of electromagnetic disturbance to enable them to operate as intended.