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The Medical Device Developer's Guide to IEC 60601-1

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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 250N for 5 seconds over an area of a circular plane with a 30mm diameter.

Impacts using a steel ball 50mm in diameter, mass of 0.5kg., dropped from a height of 1.3m.

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 9.8 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 a height, depending on its weight, for example equipment weighing less than 10kg is dropped from a height of 5cm.

Mobile equipment exceeding 45 kg must be able to pass over a 10 mm threshold. Passing over a 10 mm threshold should not result in overbalancing

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.

 

Mechanical Strength

Moving Parts

Sharp Edges

Stability

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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright © IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch . IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication. The material is reproduced or rewritten with their permission.