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5.1 Leakage Current Measurement Types and Their Allowable Values for Medical Electrical Equipment
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Class
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
Earth
leakage
current
General
equipment
0.5mA
1mA
−
−
0.5mA
1mA
−
−
0.5mA
1mA
−
−
Special
equipment
and mobile
equipment
2.5mA
5mA
−
−
2.5mA
5mA
−
−
2.5mA
5mA
−
−
Permanently
installed
equipment
5mA
10mA
−
−
5mA
10mA
−
−
5mA
10mA
−
−
Enclosure
leakage
current
A
Between
enclosure
and earth
0.1mA
0.5mA
0.5mA
0.5mA
0.1mA
0.5mA
0.5mA
0.5mA
0.1mA
0.5mA
0.5mA
0.5mA
B
Between
parts of the
enclosure
0.1mA
0.5mA
0.5mA
0.5mA
0.1mA
0.5mA
0.5mA
0.5mA
0.1mA
0.5mA
0.5mA
0.5mA
Patient
leakage
current
Direct current 0.01mA 0.05mA 0.05mA
−
0.01mA 0.05mA 0.05mA
−
0.01mA 0.05mA 0.05mA
−
Alternating
current
0.1mA
0.5mA
0.5mA
−
0.1mA
0.5mA
0.5mA
−
0.01mA 0.05mA 0.05mA
−
Patient leakage current
−
−
−
5mA
−
−
−
−
−
−
−
−
Patient leakage current
−
−
−
−
−
−
−
5mA
−
−
−
0.05mA
Patient
auxiliary
current
Direct current 0.01mA 0.05mA 0.05mA
−
0.01mA 0.05mA 0.05mA
−
0.01mA 0.05mA 0.05mA
−
Alternating
current
0.1mA
0.5mA
0.5mA
−
0.1mA
0.5mA
0.5mA
−
0.01mA 0.05mA 0.05mA
−
Class
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
−
0.5mA
0.1mA
0.5mA
−
0.5mA
0.1mA
0.5mA
−
0.5mA
B
Between
parts of the
enclosure
0.1mA
0.5mA
−
0.5mA
0.1mA
0.5mA
−
0.5mA
0.1mA
0.5mA
−
0.5mA
Patient
leakage
current
Direct current 0.01mA 0.05mA
−
−
0.01mA 0.05mA
−
−
0.01mA 0.05mA
−
−
Alternating
current
0.1mA
0.5mA
−
−
0.1mA
0.5mA
−
−
0.01mA 0.05mA
−
−
Patient leakage current
−
−
−
5mA
−
−
−
−
−
−
−
−
Patient leakage current
−
−
−
−
−
−
−
5mA
−
−
−
0.05mA
Patient
auxiliary
current
Direct current 0.01mA 0.05mA
−
−
0.01mA 0.05mA
−
−
0.01mA 0.05mA
−
−
Alternating
current
0.1mA
0.5mA
−
−
0.1mA
0.5mA
−
−
0.01mA 0.05mA
−
−
Leakage current measurement types and their allowable values for medical electrical equipment
(taken from IEC 60601-1 (1988-12) + am1 (1991-11) + am2 (1995-03))
Summary of Contents for 3155-01
Page 1: ...LEAK CURRENT HiTESTER INSTRUCTION MANUAL 3155 01...
Page 2: ......
Page 12: ......
Page 27: ...7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 A Chapter 2 Names and Functions of Parts...
Page 45: ...25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 A Chapter 4 Preparations for Measurement...
Page 243: ...223 7 7 System Screen Universal Example of a data unit printout Example of a details printout...
Page 314: ...294...
Page 322: ...302 9 3 Accuracy Tables...
Page 334: ...314 10 6 External Dimensions 292 2 110 2 212 2 115 8 2 10 6 External Dimensions...
Page 335: ...315 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 APP Appendices...
Page 362: ...INDEX 6 Index...
Page 363: ......
Page 364: ......
Page 365: ......