Hioki 3155-01, Instruction Manual

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5.1 Leakage Current Measurement Types and Their Allowable Values for Medical Electrical Equipment
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1
2
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9
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11
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A
Internally powered
equipment
Type B applied part Type BF applied part Type CF applied part
Normal
condi-
tion
Single fault condition Normal
condi-
tion
Single fault condition Normal
condi-
tion
Single fault condition
Open
power
lead *1
Open
ground
*2
110%
voltage
applied
Open
power
lead *1
Open
ground
*2
110%
voltage
applied
Open
power
lead *1
Open
ground
*2
110%
voltage
applied
Enclosure
leakage
current Ａ
Between
enclosure
and earth
0.1mA − − 0.5mA
Note 1
0.1mA − − 0.5mA
Note 1
0.1mA − − 0.5mA
Note 1
Ｂ
Between
parts of the
enclosure
0.1mA − − 0.5mA
Note 1
0.1mA − − 0.5mA
Note 1
0.1mA − − 0.5mA
Note 1
Patient
leakage
current Direct current 0.01mA
− − − 0.01mA − − − 0.01mA − − −
Alternating
current
0.1mA − − 0.1mA − − − 0.01mA − − −
Patient leakage current
− − − 5mA
Notes 1
and 2
− − − − − − − −
Patient leakage current
− − − − − − − 5mA
Notes 1
and 2
− − − 0.05mA
Notes 1
and 2
Patient
auxiliary
current Direct current 0.01mA
− − − 0.01mA − − − 0.01mA − − −
Alternating
current
0.1mA − − − 0.1mA − − − 0.01mA − − −
NOTE
*1: Interruption of one supply conductor
*2: Interruption of a protective earth conductor
Note 1 : 110% voltage application to internally powered equipment can be
either normal or reverse polarity.
Note 2 : For 250 V applications under IEC 60601-1 (1988-12) + am1 (1991-11) +
am2 (1995-03) standards, 110% voltage of the 3155’s power source
voltage is applied via the 9196 APPLY UNIT.
・ Values shown as hyphens cannot be set.
・ The measurements shown in these tables, with the exception of those for
internally powered equipment, can be set to either normal or reverse
polarity.
・ Measurements shown in the shaded portions of the tables (110% voltage
application) require the optional 9196 APPLY UNIT. The 9196 APPLY
UNIT applies 110% of the voltage it receives through its power supply inlet.
The polarity of the applied voltage can also be set to either normal or
reverse.
(Other voltage application units can also be used to make measurements.)
Conditions that cannot be established with the 3155
The following conditions are defined in IEC 60601-1 (1988-12) + am1 (1991-11)
+ am2 (1995-03), but cannot be established with the 3155.
(1) Connection to a power supply at the maximum frequency rating
(2) Connection to a power supply at 110% of the maximum voltage rating
(The 3155 supplies the power input into the power inlet directly to the
equipment to be measured.)
(3) Application of 250 V to internally powered equipment