Connectors and terminals for electrical, hydraulic, pneumatic and gas connections prevent incorrect connection of tool-free accessible connectors where that would be unacceptably risky: plugs on patient leads and cables will not fit any other outlet of that equipment unless this is shown to be harmless, and medical gas connections for different gases are not interchangeable. Temperature and overload control: no over-current release or thermal cut-out that resets automatically is used where resetting could cause a 13.1 hazardous situation; safety cut-outs reset by soldering that could alter their operating value are not fitted; where a failed thermostat could be hazardous, a separate thermal cut-out that does not reset itself is added, operating beyond the thermostat's extreme setting but within the safe limit; loss of function from a cut-out or release does not lose essential performance or cause a hazardous situation; no capacitor or spark suppressor bridges thermal cut-out contacts; safety is not affected by the cut-outs and releases, tested under clause 13 conditions with self-resetting devices and equivalent circuits operated 200 times and manual-reset devices 10 times unless approved to their IEC component standard or reliability data are provided, PTC devices verified to IEC 60730-1; heated fluid containers have protection against overheating when switched on empty, tested to activation; and tubular heating elements have overheating protection in both leads where an earth connection could overheat them; adjustable thermostat settings are clearly indicated. Batteries: housings that may release hazardous gases while the battery charges or discharges are vented so the gases cannot build up and ignite; compartments prevent accidental short circuits that could be hazardous; incorrect polarity of connection or replacement is prevented where hazardous; overcharging is prevented where risky; IEC 60086-4 applies to primary lithium batteries and IEC 62133 to secondary ones; and an internal electrical power source has an appropriately rated protective device against fire from excessive current where wiring size and layout or component ratings could allow a fire on short circuit, with adequate breaking capacity and any omission justified in the risk management file, the short-circuit test between the poles up to the first protective device omittable where two means of operator protection exist, otherwise producing none of the 13.1.2 situations. Indicators: unless apparent from the operating position, an indicator light shows that the equipment can be used normally (the 7.4.1 switch marking is not enough), an additional light shows a stand-by or warm-up state lasting over 15 s, non-luminous heaters show that they are operating where otherwise a hazardous situation might arise, an output is shown where accidental or prolonged operation could be hazardous, and a charging mode is visibly indicated. Pre-set control risks are addressed in the risk management process. In normal use, actuating parts stay fixed and cannot be detached by pulling, controls whose adjustment could be hazardous keep the scale indication matched to the control position, indicating devices separable without a tool cannot be connected incorrectly, rotating knobs withstand the Table 30 torque by gripping diameter for 2 s in each direction ten times without rotating on the shaft and a one-minute axial pull of 60 N (electrical components) or 100 N (all others), and stops of adequate strength prevent an unexpected swing from maximum to minimum where that would be hazardous, tested the same way. Cord-connected hand-held control devices meet the 15.3.4.1 drop test, foot-operated devices support an adult (1,350 N over a 30 mm area for one minute), neither changes its setting hazardously when placed in an abnormal position on a flat surface, foot-operated devices are at least IPX1, and those with electrical circuits for places where liquid is likely on the floor, for example operating theatres or emergency rooms, are at least IPX6, the probability estimated in the risk management process. Aluminium wire under 16 square millimetres is not used. Oil containers in portable equipment are sealed against loss in any position with room for expansion, in mobile equipment sealed for transport with a pressure-release device allowed in use, and partially sealed oil-filled parts have a means of checking oil level to detect leakage.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.