DGUV V3 / DIN EN 62353 Testing
Recurring tests and post-repair tests on medical electrical equipment
DIN EN 62353 - The Testing Standard for Medical Devices
DIN EN 62353 (VDE 0751-1) is the international testing standard for medical electrical equipment and systems. It covers three types of tests:
- ✓ Recurring tests during normal operation
- ✓ Post-repair tests (after every repair)
- ✓ Tests before recommissioning
Testing Procedure
The testing procedure consists of three sequential steps:
1. Visual Inspection
Housing damage, cable damage, type plates and faulty repairs are visually inspected.
2. Electrical Measurements
- Protective earth resistance (Class I devices)
- Insulation resistance (Class II devices)
- Equipment leakage current
- Touch current
- Patient leakage current (for BF/CF applied parts)
3. Functional Testing
Functional testing according to manufacturer specifications – only performed if the visual and measurement tests have been passed.
Which Devices Are Tested?
DIN EN 62353 applies to all medical electrical equipment, in particular:
- Ultrasound devices
- Laboratory equipment
- Hospital beds (electric)
- Examination tables
- Patient lifts
- ECG devices
- Blood pressure monitors
- All other ME devices according to DIN EN 60601-1
Particularly relevant: For non-Annex 1 devices, DIN EN 62353 is the central safety test within the framework of DGUV Vorschrift 3.
Recommended Testing Intervals
The standard itself does not prescribe fixed intervals. Recommended intervals are 6 to 36 months, typically 12-24 months. Manufacturer specifications take precedence.