IEC 60601-1 - Medical Electrical Equipment Safety 15.3: Mechanical strength

What does 15.3 require?

Equipment and parts have adequate mechanical strength and keep their basic safety and essential performance despite moulding stress or from pushing, impact, dropping and rough handling, tested per Table 28 by equipment type (hand-held: push, drop, mould stress relief; body-worn: push, drop, mould stress; portable: push, drop, mould stress; mobile: push, impact, rough handling, mould stress; fixed or stationary: push, impact, mould stress), excluding handles, levers, knobs, CRT faces and transparent covers unless their removal creates a shock risk, and judged by the clause 8 and 11.6 criteria, the dielectric strength of insulation that forms a means of protection, and measured creepage and clearance, small chips being ignorable. Enclosure rigidity is tested with a steady 250 N over a 30 mm disc for 5 s on external parts (not the bottom of equipment over 18 kg); impact resistance of enclosures and external insulating parts other than hand-held, flat panel displays, platen glass and CRTs by a 500 g, 50 mm steel ball dropped 1.3 m onto each relevant part or swung as a pendulum against vertical surfaces; hand-held equipment, accessories and parts by a free fall with safe working load from the use height or 1 m, whichever is greater, once from each of three orientations onto 50 mm hardwood on concrete; portable equipment three times from each normal-use orientation from the Table 29 height by mass onto hardwood; mobile equipment in transport position with safe working load by three ascending-step shocks against a 40 mm step at 0.8 m/s or maximum motor speed, three descending-step drops off a 40 mm step, and three door-frame shocks against a 40 mm vertical obstacle; moulded or formed thermoplastic enclosures by 7 hours in an oven at 10 degrees above the maximum enclosure temperature of the 11.1.3 test but at least 70 degrees, unless construction and data suffice; and the selection and treatment of materials take account of intended use, expected service life and transport and storage conditions so that corrosion, ageing, wear or biological degradation does not reduce mechanical properties to an unacceptable risk, checked against material and processing specifications and the manufacturer's tests or calculations.