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Mechanical Strength The enclosure of the device must be sufficiently strong to retain its integrity under conditions of normal wear and tear.
To test this it is subjected to various tests: An inward force of 45N over an area of 625 mm2. Impacts with an energy of 0.5J. After
these tests, the device must not produce a safety hazard, e.g. live parts must not be accessible. Handles of portable equipment are tested with a force of four times the
weight of the product. If there is more than one handle, this weight is distributed between the handles. Parts which support patients, or
patient limbs, e.g. foot rests, as well as suspended parts of the device which could injure patients or operators, are subjected to forces, including a safety factor, in order to
ensure their suitablility. Clause 28 of the standard specifies the safety factor to be used.Hand held part are submitted to a drop test from a height of 1m.
Portable equipment is dropped from depending on its weight, for example equipment weighing less than 10kg is dropped from a height of 5cm. Mobile equipment is made to
travel at 0.4m/s down a step of 2cm. This test is repeated 20 times. After these tests the equipment should not cause a safety hazard, that is it should comply with
the requirements of the standard. Moving Parts Moving parts which could produce a safety hazard must be suitable guarded to prevent access, unless exposure
is essential to the operation of the equipment.If movement of the equipment, or parts of the equipment can cause injury to the patient, this movement can only be
achieved by continuous operation of the control by the operator. Any electrically controlled mechanical movement must have an emergency switch.
Sharp Edges The device must not have sharp edges, corners, etc. Stability Medical devices must not overbalance when tilted
to an angle of 10°. |
