ES601Plus OPERATING MANUAL
The advantage of the "Alternative Method" or "Direct Method" of leakage testing under VDE-0751 is
either method requires far fewer leakage measurements than either the IEC60601 standard or AAMI-ES1
standard. VDE-0751 allows safety tests to be completed much more rapidly, particularly when executed by
ES601Plus.
Another electrical safety standard provided by ES601Plus, designated IEC62353, is a standard developed by
IEC for medical device safety tests following repair service of equipment. The IEC62353 standard is similar
to VDE-0751, particularly with respect to leakage testing. A significant difference, however, is that VDE-
0751 specifies acceptance limits for the insulation resistance test, whereas IEC62353 requires the test to be
performed but does not specify a limit. Additionally, VDE-0751 specifies DC limits for certain leakage
measurements, whereas IEC62353 does not.
For VDE-0751 and IEC62353 standards, ES601Plus records all results from all leakage measurements
enabled by the user in the test setup. For the "direct method" of measurement, ES601Plus will record AC
and DC values for these test conditions:
Device Leakage:
Normal Polarity Single-Fault Condition, Earth Open (NP:SF EO)
Reverse Polarity Single-Fault Condition, Earth Open (RP:SF EO)
Patient Leakage (record for each Group defined by the user):
Normal Polarity Normal Condition
(2)
SFC, Mains on Applied Part(s)
(NP:NC)
(NP:SF MAP)
Reverse Polarity Normal Condition
(2)
SFC, Mains on Applied Part(s)
(RP:NC)
(RP:SF MAP)
(2) VDE-0751 only: normal condition (applied part(s) to protective earth) is measured if user enables "per
IEC60601" method in the test setup.
2.1.11 Battery-Power Protocols
If the DUT is an internally-powered device, and cannot be operated from or connected to the AC line, then
a subset of the above tests is applicable. If the DUT is defined as battery-powered by the user, ES601Plus
will test only patient leakage and auxiliary leakage of the DUT, and measure insulation resistance of the
applied parts to protective earth.
Overview/Chapter 2 # Page 16
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