A.4 System Tests Based on IEC 601.1/UL 2601.1
1. Test SYS. 1 - Enclosure Leakage Current: Normal Condition
• Applicable to Classes 1 and 2, Types B, BF and CF.
• Measures leakage current of the exposed metal parts of the instrument under test and between
parts of the system within the patient environment; normal and reversed polarity using S2.
• Maximum leakage current: 100 µA (Range: DC and AC up to 1 kHz).
2. Test SYS. 2 - Enclosure Leakage Current: S.F.C. Open Earth (Ground)
• Applicable to Class 1, Types B, BF and CF.
• Measures leakage current of the exposed metal parts of the instrument under test with Protec-
tive Earth open circuit (S4 = open), and between parts of the system within the patient envi-
ronment; normal and reversed polarity using S2.
• Maximum leakage current: 500 µA (Range: DC and AC up to 1 kHz).
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