Paragraph 8 Requirements as to design and construction
The device shall be designed and manufactured in such a way as to remove or minimise so far as is possible—
the risk of physical injury arising out of its physical features (including its dimensions);
risks connected with the use of sources of energy, including, in the case of a device which uses electricity, risks arising from lack of adequate insulation, from leakage currents and from overheating;
risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure, variations in pressure and acceleration;
risks connected with medical treatment, in particular those resulting from the use of defibrillators or high—frequency surgical equipment;
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, and
decreased accuracy of any measuring or control mechanism.
Annotations
Footnotes
- f1
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OJ No. L246, 17.9.80, p. 1.
- f2
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OJ No. L265, 5.10.84, p. 4.
- f3
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OJ No. L265, 5.10.84, p. 1.