IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 9 to 10: mechanical and radiation hazards – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 9.4: Instability hazards

What does 9.4 require?

Equipment and parts other than fixed and hand-held equipment intended to stand on a floor or table do not tip over or move unexpectedly to a degree that creates unacceptable risk, each of the following tests performed separately with the equipment prepared with all leads and cords, the least favourable detachable parts, accessories and load, castors blocked in the worst position, doors, drawers and shelves and liquid containers in the worst condition, unpowered, on a hard flat vinyl-covered floor: no overbalance in any transport position on a 10-degree incline; no overbalance in any other normal-use position on a 5-degree incline, and if it overbalances at 10 degrees a warning that transport is only in a described condition; equipment of 25 kg or more used on the floor either does not overbalance under a force of 15 percent of its weight up to 150 N applied in any non-upward direction at up to 1.5 m against a 20 mm floor obstruction, or carries a permanent legible warning visible in normal use but not on surfaces meant for pushing; equipment used on floor or table either does not overbalance when 800 N is applied where it produces the greatest moment on any obvious foothold or sitting surface of at least 20 by 20 cm up to 1 m high, or carries a legible warning visible during such misuse. Castors and wheels of mobile equipment cause no unacceptable risk when moved or parked: the propulsion force on a hard flat floor at 0.4 m/s applied at 1 m stays at or below 200 N unless the instructions call for more than one person; mobile equipment over 45 kg passes ten times over a 10 mm threshold with 2 mm radiused edges in transport position with safe working load at 0.8 m/s (or maximum motor speed) without overbalancing, damage or loss of basic safety and essential performance; brakes of power-driven mobile equipment are normally applied and released only by continuous actuation; locking devices prevent unwanted movement in transport position; wheel locks or brakes hold on a 10-degree incline in transport position and on 5 degrees in other positions with no more than 50 mm movement after initial settling, and hold against a lateral force of 15 percent of weight up to 150 N at up to 1.5 m with no more than 50 mm movement. Equipment over 20 kg needing lifting has handling devices or documented lifting points unless handling is obvious and safe, handles placed for two or more persons; portable equipment over 20 kg has carrying handles for two or more persons; and handles on portable equipment withstand four times the equipment weight in any direction of use, distributed by measured share or each taking the full force where one handle can carry it, applied over 7 cm at the centre over 5 to 10 s and held for one minute without breaking loose, permanent distortion or cracking.

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