Tests 3 Testing and Maintenance
49
Safety Test Procedures
Use the test procedures outlined here only for verifying safe installation or service of the product. The
setups used for these tests and the acceptable ranges of values are derived from local and international
standards but may not be equivalent. These tests are not a substitute for local safety testing where it is
required for an installation or a service event. If using the Metron Safety tester, perform the tests in
accordance with your local regulations, for example in Europe use IEC60601-1/IEC60601-1-1 and in
the US use UL2601-1. The Metron Report should print results with the names listed below, together
with other data.
S(1) Part 1: System Enclosure Leakage Current - NC (normal condition)
Expected test results:
♦ Normal condition maximum leakage current x1 ≤ 100µA
This 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
(*) 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
(**)