STK - Safety Testing for Cosmetic Devices
Legally required STK testing for cosmetic devices classified as medical products - laser, IPL, RF and more
Why do cosmetic devices need STK testing?
Many devices used in cosmetic studios and aesthetic practices are classified as medical devices under the EU Medical Device Regulation (MDR). This applies particularly to devices listed in Annex 1 of the MPBetreibV - devices that actively affect the human body.
For these devices, Section 12 of the German Medical Device Operator Ordinance (MPBetreibV) mandates regular safety testing (STK - Sicherheitstechnische Kontrolle). The STK is not a voluntary measure but a legal obligation for the operator.
Which cosmetic devices require STK testing?
The deciding factor is whether the device is approved as a medical product and bears a CE marking under MDR. Typical cosmetic devices requiring STK:
- IPL devices (Intense Pulsed Light) - for hair removal and skin rejuvenation
- Laser devices - medical lasers for hair removal, tattoo removal, vascular treatment
- Radiofrequency devices (RF) - skin tightening, RF lifting, Thermage
- HIFU devices (High-Intensity Focused Ultrasound)
- Cryolipolysis devices with medical device approval
- Microneedling devices with electric drive
- LED therapy devices with medical intended purpose
- EMS and electrostimulation devices (medical products)
What does the STK testing include?
- ✓ Visual inspection - condition of housing, cables, plugs, handpieces, type plates and warning labels
- ✓ Functional testing - verification of all safety-relevant functions, emergency stop, protective mechanisms and sensors
- ✓ Measurement testing - protective conductor resistance, insulation resistance, leakage current measurement per DIN EN 62353
- ✓ Labelling check - CE marking, UDI, manufacturer information, instructions for use
- ✓ Documentation - complete STK test report, test label and entry in the medical device logbook
STK testing intervals for cosmetic devices
Testing intervals are determined by the manufacturer's instructions for use. Typical intervals:
- ✓ Every 1-2 years - depending on manufacturer specifications and device class
- ✓ After every repair - renewed STK required before recommissioning
- ✓ No manufacturer specification? - At least every 2 years per Section 12 MPBetreibV
Benefits of regular STK testing
- ✓ Legal compliance - fulfilment of operator obligations under MPBetreibV and MDR
- ✓ Insurance protection - many insurers require current STK certificates as a prerequisite for coverage
- ✓ Device safety - early detection of wear, defects and safety deficiencies
- ✓ Liability protection - in case of damage, STK documentation proves proper maintenance
- ✓ Regulatory audits - you are on the safe side during inspections by supervisory authorities
STK vs. NiSV - What is the difference?
The STK under Section 12 MPBetreibV applies to devices approved as medical products. The NiSV, on the other hand, regulates the use of devices with non-ionizing radiation - regardless of medical device classification. Many cosmetic devices fall under both regulations. We test your devices comprehensively and cover both STK and NiSV requirements in a single appointment.
Who may perform the STK?
The STK may only be performed by persons with the required expertise. As a TÜV Süd certified tester according to DIN EN 62353 with extensive experience in electrical engineering, we meet all requirements. Testing is performed independently of the manufacturer and without external directives.