AS 62052.21:2018 pdf free.Medical electrical equipment Part 2.26: Particular requirements for the basic safety and essential performance of electroencephalographs.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS Clause 11 of the general standard applies, except as follows:
201.11.6.3 *spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT separable while remaining functioning shall be so constructed so that, in the event of spillage of liquids (accidental wetting), no HAZARDOUS SITUATION results from the ingress of liquids.
The ME EQUIPMENT shall meet the dielectric strength requirements specified in 8.8.3 of the general standard and shall comply with the requirements of this particular standard.
Compliance is checked by the following test:
Place the PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT in the least
favourable position of NORMAL USE. Subject the ME EQUIPMENT for 30 s to an artificial rainfall of 3 mm/mm falling vertically from a height of 0,5 m above the top of the ME EQUIPMENT.
A test apparatus is shown in Figure 3 of IEC 60529.
An intercepting device may be used to determine the duration of the test.
Immediately after 30 s exposure, remove any visible moisture on the ENCLOSURE.
Immediately after the above test, verify (by inspection) that any water that entered the
ME EQUIPMENT cannot adversely affect the BASIC SAFETY of the ME EQUIPMENT. Verify that the
ME EQUIPMENT meets the relevant dielectric strength test (8.8.3 of the general standard) and
does not result in a HAZARDOUS SITUATION.
After this test, verify that the ME EQUIPMENT complies with the requirements of this particular standard.
201.11.8 *Interruption of the power supply I SUPPLY MAINS to ME EQUIPMENT
Addition:
If the SUPPLY MAINS to the ME EQUIPMENT IS interrupted for less than 30 s, no change of OPERATOR settings shall occur, including the mode of operation, or all stored PATIENT data shall remain available.
NOTE The ME EQUIPMENT does not have to remain in operation during the interruption of the SUPPLY MAINS.AS 62052.21 pdf download.