Guide & Articles

Expert knowledge on device testing, NiSV, DGUV V3 and medical technology

Frequently Asked Questions

DGUV V3 & Electrical Testing

Yes! Devices not listed in Annex 1 of the MPBetreibV (e.g., ultrasound devices, laboratory equipment, care beds) must also be regularly tested according to DGUV Vorschrift 3 / DIN EN 62353. DGUV V3 applies to all electrical equipment — regardless of whether it is a medical product or not.
The standard recommends test intervals of 6 to 36 months, typically 12–24 months. Manufacturer specifications take precedence. After every repair, a post-repair test is mandatory. The specific interval results from the operator's risk assessment.
According to §5 MPBetreibV, three requirements must be met: 1) Current knowledge from appropriate training, 2) Independence in technical assessments, 3) Suitable equipment. Alexander Driller meets all three requirements and is TÜV Süd certified.
STK (Safety Technical Inspection) checks the safety of medical products per §12 MPBetreibV. MTK (Metrological Control) checks measurement accuracy per §15 MPBetreibV. DGUV V3 checks the electrical safety of all equipment. Many devices require multiple tests. Detailed comparison →

NiSV & Cosmetic Devices

The NiSV covers devices emitting non-ionizing radiation: Lasers, IPL, RF/high-frequency, ultrasound (above thresholds), magnetic field, low-frequency/EMS and direct current. Simple devices like LED masks or mechanical microdermabrasion are not covered. More about NiSV →
NiSV violations can be fined up to 50,000 EUR per violation (§8 Para. 3 NiSG). Additionally, business closures and competition law warnings from competitors are possible. State authorities have been systematically enforcing since 2024.
Yes! Even pure cosmetic devices without medical product approval must be tested under DGUV Vorschrift 3 — this applies to every facial steamer, UV nail lamp and wax heater. Testing follows DIN VDE 0701-0702 (or the new standards DIN EN 50678/50699). More details →

Testing Intervals & Costs

Recommended intervals depend on device type: STK-mandatory medical products (Annex 1): every 2 years. Other medical products: 6–24 months. Pure cosmetic devices: 6–24 months per DGUV V3. Manufacturer specifications always take priority. After every repair, immediate re-testing is mandatory. Full overview →
Costs depend on device count and test type. DGUV V3 per device: approx. 10–15 EUR net. DIN EN 62353 per medical device: approx. 30–80 EUR net. STK per device: approx. 60–100 EUR net. We offer package prices for cosmetic studios. Request a free quote →
Yes, absolutely. Testing a single device takes only a few minutes (DGUV V3: 3–10 min, STK: 15–30 min). We schedule appointments to minimize disruption. Typically, a complete studio with 10–15 devices can be tested in 2–3 hours.