Device Testing for Aesthetic Practices
Comprehensive testing of medical devices and cosmetic equipment - DIN EN 62353, DGUV V3, STK and NiSV
The Special Challenge: Medical Devices and Cosmetic Equipment
Aesthetic practices and beauty clinics use a mix of medical devices and cosmetic equipment. For testing, this means: different standards and regulations apply depending on the device classification. Medical devices are tested according to DIN EN 62353, all other electrical equipment according to DIN VDE 0701-0702.
With MDR Annex XVI, effective since June 2023, numerous aesthetic devices without a medical purpose will be regulated as medical devices for the first time. This particularly affects lasers, IPL, HIFU and radiofrequency devices for purely aesthetic applications.
Typical Devices in an Aesthetic Practice
- IPL devices (Intense Pulsed Light) - hair removal, photorejuvenation
- Laser devices - Nd:YAG, Alexandrite, diode laser
- HIFU devices (High-Intensity Focused Ultrasound) - lifting, body forming
- Cryolipolysis devices - fat reduction
- Radiofrequency devices (RF) - skin tightening, Thermage
- Plasma pen / Fibroblast - eyelid tightening, scar treatment
- EMS body forming devices
- Injection devices and mesotherapy systems
- Microneedling devices (electric)
- LED therapy devices
- Autoclaves and sterilizers
Which Tests Are Required?
| Device Type | Test Standard | Legal Basis |
|---|---|---|
| Medical devices (Class I-III) | DIN EN 62353 | DGUV V3 / MPBetreibV |
| Medical devices Annex 1 | DIN EN 62353 + STK | §12 MPBetreibV |
| Cosmetic devices (non-medical) | DIN VDE 0701-0702 | DGUV V3 |
| NiSV-relevant devices | Electrical safety testing | NiSV |
MDR Annex XVI - What Changes from 2025?
New Regulation for Aesthetic Devices
Since June 2023, devices without a medical purpose listed in Annex XVI of the EU Medical Device Regulation (MDR) will fall under medical device regulation. This means: devices such as lasers, IPL and HIFU that were previously only considered cosmetic devices must be certified as medical devices and tested accordingly - including STK per §12 MPBetreibV.
Benefits of a Maintenance Contract
Aesthetic practices typically have a high number of devices with different testing intervals. A maintenance contract offers you:
- ✓ Deadline monitoring - I remind you of upcoming tests in good time
- ✓ Predictable costs - Fixed annual price for all tests
- ✓ Priority service - Preferred scheduling, even at short notice
- ✓ Device records - Complete documentation of all tests and repairs
- ✓ All testing from one source - DIN EN 62353, DIN VDE 0701-0702, STK and NiSV
Combined Testing Saves Time and Money
For practices with many devices, an annual testing appointment is particularly worthwhile: I test all devices - regardless of classification and standard - in one appointment. This minimizes downtime and saves compared to individual tests.