Safety Tests
Performance Verification Testing
3-26 Efficia CM Series Service Guide
Note — Safety tests meet the standards of, and are performed in accordance with
IEC 60601-1, Clause 8 (EN60601-1).
The monitor safety tests include:
• Ground integrity
• Touch leakage — 4 parts
• Patient leakage current with mains voltage
To perform these tests, you need one of the following:
• Multimeter with a leakage network
• Product safety analyzer
Ground Integrity Testing
Figure 3-1 S(1) Protective Earth Continuity
Expected Test Results:
With mains cable, maximum impedance x 200 mOhms (IEC 60601-1 and ES 60601-1)
This measures impedance of Protective Earth (PE) terminal to all exposed metal parts
of Instrument under Test (IUT), which are for safety reasons connected to the
Protective Earth (PE). Test current 25 Amp applied for 5 to 10 seconds.
Touch Leakage Testing
All monitors require the touch leakage tests part 1 and part 2. If the monitor under test
is part of a medical electrical system, such as an EHR, you must also perform “Touch
Leakage, Part 3” on page 3-28 and “Touch Leakage, Part 4” on page 3-28.
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