Safety Testing (STK)
Legally required testing in accordance with §12 MPBetreibV for active medical devices
What is the STK?
The Safety Testing (STK) is a legally required periodic test in accordance with §12 MPBetreibV for all active, non-implantable medical devices listed in Annex 1 MPBetreibV. It ensures that medical devices function safely and pose no risk to patients and users.
Which devices must be tested?
All active medical devices listed in Annex 1 MPBetreibV, including:
- Defibrillators
- HF surgical devices
- Medical lasers
- Infusion pumps & syringe pumps
- Dialysis machines
- Ventilators
- MRI machines
- Incubators
- Anaesthesia machines
- Patient monitoring devices
What is tested during the STK?
The STK covers significantly more than a simple electrical safety test:
- ✓ Electrical safety testing in accordance with DIN EN 62353 (protective earth resistance, insulation resistance, leakage currents)
- ✓ Monitoring, safety and alarm systems – functional testing
- ✓ Device-specific functional testing (e.g., energy output measurement for defibrillators, volume measurement for ventilators)
- ✓ Mechanical safety testing
- ✓ Manufacturer-specific test checklists
- ✓ Comprehensive documentation and final assessment
Testing Intervals
The legal maximum interval is 24 months. The manufacturer may specify shorter intervals, which are then binding. We remind you in advance of upcoming tests.
Your Benefits with Medizintechnik Driller
- ✓ Complete STK including all sub-tests from a single source
- ✓ Device-specific expertise and current manufacturer specifications
- ✓ On-site testing at your practice/hospital
- ✓ Complete documentation for your regulatory files
- ✓ Automatic reminder service for your next test
Legal Notice
The STK is legally required (§12 MPBetreibV, version from February 2025). Operators are obligated to have STK-required devices tested on time. Violations may result in fines and liability risks in case of damage. Alexander Driller meets all requirements under §5 MPBetreibV for performing STK.