IEC 60601-1 - Medical Electrical Equipment Safety 11.6: 11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME equipment

The construction adequately withstands overflow, spillage, leakage, entry of water or particles, cleaning, disinfection and sterilisation, and is compatible with the substances the equipment is used with. Overflow from a reservoir liable to overfilling does not wet any means of protection it could affect, and basic safety and essential performance are kept: with a marked maximum fill level and a warning, no hazard develops filled to capacity and tilted 10 degrees or, for mobile equipment over 45 kg, moved over the threshold; without such a warning, the same holds filled 15 percent over capacity, poured in over one minute, tilted 10 degrees in the least favourable direction; afterwards the equipment passes the leakage current and dielectric strength tests, with no wetting of uninsulated parts or insulation. Equipment handling liquids in normal use or used where the risk management process finds spillage likely is built so that spilled liquid cannot wet parts whose wetting would probably compromise basic safety or essential performance, tested by pouring the liquid, volume, duration and point the risk analysis determines and documents onto the top, then the dielectric and leakage tests with no wetting. Enclosures classified for ingress protection meet IEC 60529's tests in the least favourable position with no bridging of insulation, followed by the dielectric and leakage tests. Equipment, parts, applied parts and accessories withstand the cleaning and disinfection processes the instructions specify without their safety provisions being damaged or degraded, the manufacturer evaluating the effect of repeated cleaning over the service life and documenting it, tested by one cleaning or disinfection per the methods including cooling or drying, then inspection and the dielectric and leakage tests. Parts intended to be sterilised are assessed and documented under ISO 11135, 11137 or 17665 as applicable, then inspected and tested the same way. The risk management process deals with compatibility with the substances the equipment is used with, through standards such as ISO 15001 for oxygen components above 50 kPa or the manufacturer's own testing and controls.