Paragraph 9 Requirements as to design and construction

The device shall be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in paragraphs 1 to 5 with particular attention being paid to—

(a)

the choice of materials used, particularly as regards toxicity;

(b)

mutual compatibility between the materials used and biological tissues, cells and body fluids (acccount being taken in accordance with regulation 3(2) of the intended use of the device);

(c)

compatibility of the device with any substances which it is intended to administer;

(d)

the quality of the connections, particularly where considerations of safety are involved;

(e)

the reliability of the source of energy;

(f)

if appropriate, the need to make it leakproof;

(g)

proper functioning of the programming and control systems, including software.