S.L. 427.16 · Diagnostic Medical Devices (S.L. 427.16)
S.L. 427.16 ст. 2construction the generally solutions, the design and to risks of the
The solutions adopted by the manufacturer for the design and of the devices must conform to safety principles, taking account of acknowledged state of the art. In selecting the most appropriate manufacturer must apply the following principles in the following order: - eliminate or reduce risks as far as possible (inherently safe construction), - where appropriate take adequate protection measures in relation that cannot be eliminated, - inform users of the residual risks due to any shortcomings protection measures adopted.