Equipment has two means of protection that keep applied parts and other accessible parts within the 8.4 limits, each categorised as a means of patient protection (protecting applied parts or 4.6 parts) or a means of operator protection; varnish, enamel, oxidation and replasticisable sealing compounds are never a means of protection; where components and wiring make up a means of protection, they meet 8.10; and any insulation, distance, component or earth connection not meeting the MOPP or MOOP requirements is not a means of protection and its failure is normal condition. A means of patient protection is solid insulation passing the 8.8 dielectric strength test at the Table 6 voltage, creepage and clearance within Table 12, a protective earth connection meeting 8.6, or a Y1 or Y2 capacitor to IEC 60384-14 counted as one MOPP (two in series of identical type and capacitance, meeting the dielectric strength for their use; a single Y1 counts as two MOPP where the working voltage is under 60 V for d.c., or for a.c. 42.4 V peak). A means of operator protection may instead meet IEC 60950-1 insulation coordination or protective earthing, Tables 13 to 16 for distances, a Y2 counting as one MOOP and a Y1 as two. Compliance is checked by examining the physical and electrical configuration to find every point where insulation, distances, component impedance or earth connections prevent limits being exceeded (Annex J surveys the paths), classifying each and deciding whether its failure is normal or single fault condition, and determining working voltage by inspection, calculation or measurement. An F-type applied part keeps its patient connections apart from every other part, including the connections of other applied parts, by one MOPP rated for a working voltage matching the maximum mains voltage, and they meet the patient leakage limit with 110 percent of maximum mains voltage applied, functions within one F-type part needing no separation between them and unseparated connections counting as one applied part, with any protective device to the enclosure operating at not less than 500 V r.m.s.; unearthed type B patient connections are separated by one MOPP from unearthed metal accessible parts unless contiguous with the applied part and at acceptably low risk; connectors at the equipment end of patient leads whose conductive parts lack one MOPP from the patient connections cannot touch a 100 mm flat conductive plate, keep 0.5 mm clearance from a flat surface, are protected from mains socket contact by 1 mm creepage and 1,500 V insulation, and resist the straight test finger at 10 N, unless risk management shows the risk is acceptable. Maximum mains voltage means the top rated supply voltage (250 V where that is under 100 V), the highest phase-to-neutral voltage for polyphase, and 250 V for other internally powered equipment; working voltage is determined at the rated voltage giving the highest value, as the average d.c. or the peak above 10 percent ripple, across the whole of double insulation, with an earthed patient as normal condition, at the highest voltage across F-type isolation in normal use, without regard to defibrillation voltages, and at motor resonance voltage where it can occur. Defibrillation-proof classification applies to a whole applied part: during a defibrillator discharge, hazardous energy (over 1 V peak between the test points) does not appear on the enclosure including connected patient lead connectors, signal input and output parts, the foil under the equipment, other applied parts' connections, or unused connections of the part, body-worn equipment excepted, and after exposure and any stated recovery time the equipment keeps basic safety and essential performance, tested in common mode and differential mode with and without protective earth, foil or saline on insulating surfaces, and with the test voltage reversed; and the energy delivered to a 100 ohm load through the applied part with its recommended accessories is at least 90 percent of that delivered with the equipment disconnected, tested from a 5 kV capacitor discharge in both polarities.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.