The Ordinance on Protection against the Harmful Effects of Non-Ionizing Radiation (e.g., Laser, Intense Light, Radio Frequency, Electrostimulation, Ultrasound) in Human Applications (NiSV) is applicable to equipment that emits non-ionizing radiation and is used for cosmetic, non-medical purposes on humans.
The operator must ensure, among other things, that protective measures are taken to protect the treated person or third parties from avoidable health hazards, that certain documentation and notification obligations are complied with, and that maintenance is carried out in accordance with the manufacturer's instructions. The persons using the equipment must also be instructed in its proper handling and must be able to prove that they have the necessary technical knowledge or have attended training courses.
The operator must report the following equipment to the responsible trade supervisory office:
- Laser devices and intense light sources, for example for permanent hair removal or tattoo removal,
- High-frequency devices, for example for wrinkle smoothing or fat reduction,
- Equipment for electrical nerve and muscle stimulation (for example, for muscle building in sports studios) and for magnetic field stimulation (for example, magnetic field mats),
- equipment for stimulating the central nervous system, for example brain stimulation for performance enhancement,
- ultrasound equipment, for example ultrasound baby monitors or for fat reduction and
- Magnetic resonance tomographs, for example brain examinations in market research.
The requirement to provide proof of expertise comes into effect on Dec. 31, 2022.