ANNEX IU.K.ESSENTIAL REQUIREMENTS

B.DESIGN AND MANUFACTURING REQUIREMENTSU.K.

6.Requirements for medical devices connected to or equipped with an energy sourceU.K.

6.4.Protection against mechanical and thermal risksU.K.

6.4.1.Devices must be designed and manufactured in such a way as to protect the user against mechanical risks. Devices must be sufficiently stable under the foreseen operating conditions. They must be suitable to withstand stresses inherent in the foreseen working environment, and to retain this resistance during the expected life of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer.U.K.

Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means must be incorporated.

Any guards or other means included with the device to provide protection, in particular against moving parts, must be secure and must not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer.