Patient Safety Checks
160
Testin
the Instrument
S(1) Part 1: System Enclosure Leakage Current - NC (normal condition)
Expected test results:
Normal condition maximum leakage current x1 ≤ 100µA
Measures leakage current of exposed metal parts of Instrument under Test (IUT) and between
parts of the system within the patient environment; normal and reversed polarity using S2.
Safety test according IEC 60601-1 / UL2601-1
S(1) Part 2: System Enclosure Leakage current - Single Fault (open earth)
(*) Not present in Class 2.
(**) Can be multiple different connections to different equipment at same time.
PE
Instrument under test
Applied part
(*)
S4
N (L)
S1
S2
L (N)
Signal parts
in- and/or
output
MD
Medical electrical system
Signal parts
in- and/or
output
Other
Instrument
(**)
(**) Can be multiple different connections to different equipment at same time.
PE
Instrument under test
Applied part
S4
N (L)
S1
S2
L (N)
Signal parts
in- and/or
output
MD
Medical electrical system
Signal parts
in- and/or
output
Other
Instrum ent
(**)