7 Testing and Maintenance
90
NOTE
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
Evaluation
System
(Sys 1-2)
Perform the system
test according to sub
clause 19.201 of
IEC 60601-
1:2005+A1:2012/
EN 60601-
1:2006+AC:2010, if
applicable, after
forming a system.
Equipment Leakage Current:
Sys1 <= 100 µA (Normal
Condition)
Sys2 <= 300 µA (Single Fault
Condition)
Sys:PSys1/PSys2 or
Sys:FSys1/FSys2
System
(Sys 3)
Perform the system
test according to sub
clause 19.201 of
IEC 60601-
1:2005+A1:2012/
EN 60601-
1:2006+AC:2010, if
applicable, after
forming a system.
Protective Earth Leakage
Current if medical electrical
system components are
connected to the same Multiple
Portable Socket-Outlet:
Sys3 <= 300 µA
Sys: PSys3 or
Sys: FSys3
Key: P = Pass, F = Fail, X = test result value to be recorded
Test Block Test or Inspection
to be Performed
Expected Test Results Record the Results (mandatory for
Philips Personnel only)
What to Record Actual Results
Yes No
Safety and Functional Test passed
Repair required at a later date, safety and functional test passed
Device must be taken out of operation until repair and passed tests
Device failed and must be taken out of operation.
Notes:
Next Recurrent Test:
Name:____________________________________________________
Date/Signature:_____________________________________________
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