Device Testing for Medical Practices
STK, DGUV V3 and DIN EN 62353 for all medical and electrical devices in your practice
Testing Requirements for Medical Practices
As operators of medical devices, medical practices are subject to extensive testing obligations. The MPBetreibV (Medical Device Operator Ordinance) mandates regular safety technical inspections, while DGUV Vorschrift 3 requires testing of all electrical equipment. As a TÜV Süd certified inspector per DIN EN 62353, I handle both types of testing for your practice.
Typical Devices in a Medical Practice
- ECG devices
- Ultrasound devices (sonography)
- Defibrillators (AED and manual)
- Blood pressure monitors (electric)
- Laboratory equipment and centrifuges
- Infusion pumps and syringe pumps
- Electric patient beds and examination chairs
- Inhalation devices
- Pulse oximeters
- Spirometers (pulmonary function test)
- Ergometers (stress ECG)
- Sterilizers and autoclaves
Which Tests Are Required?
| Test | Legal Basis | Devices |
|---|---|---|
| STK (Safety Technical Inspection) | §12 MPBetreibV | Annex 1 devices (e.g., defibrillators, infusion pumps, ergometers) |
| DIN EN 62353 | DGUV V3 / MPBetreibV | All medical electrical devices |
| DIN VDE 0701-0702 | DGUV V3 | All other electrical equipment (PC, printer, coffee machine, etc.) |
STK per §12 MPBetreibV
The safety technical inspection is legally required for all devices listed in Annex 1 of the MPBetreibV. In medical practices, this particularly concerns:
- ✓ Defibrillators - AED and manual defibrillators
- ✓ Infusion pumps - All active infusion and syringe pumps
- ✓ Ergometers - For stress ECG
- ✓ Electrosurgery devices - If present
DIN EN 62353 - All Medical Devices
For all medical electrical devices not covered by Annex 1, the periodic test per DIN EN 62353 is the central safety test. It includes:
- ✓ Visual inspection - Housing, cables, plugs, applied parts
- ✓ Protective conductor resistance - For Class I devices
- ✓ Insulation resistance - For Class II devices
- ✓ Leakage current measurement - Substitute leakage, touch current, patient leakage current
- ✓ Functional test - Per manufacturer specifications
Aesthetic Devices in Your Practice?
Many medical practices expand their services to include aesthetic treatments - with IPL, laser, HIFU or RF devices. I naturally include these in the testing: depending on classification per DIN EN 62353 (medical devices) or DIN VDE 0701-0702 (cosmetic devices). For NiSV-relevant devices, I provide the corresponding test certificate.
Recommended Intervals
Manufacturer specifications always take precedence. Typical intervals: STK every 1-2 years, DIN EN 62353 periodic test every 12-24 months. After every repair, retesting before recommissioning is mandatory.