Cosmetic application of non-ionizing radiation; notification of operation of equipment
The operation of commercial facilities that use non-ionizing radiation for cosmetic and other non-medical purposes on humans must be reported to the responsible trade supervisory office.
Description
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.
Prerequisites
Persons using the equipment must have the required expertise (comes into force from 31.12.2022).
Procedure
In the notification, the name or the company of the operator as well as the address of the operating site and the information for the identification of the respective system must be stated.
The installations or laser systems covered by the NiSV or certificates of expertise (as of 31.12.2022) are to be sent to the trade supervisory office responsible for the administrative district.
Special notes
As of December 31, 2020, the following procedures may only be performed by licensed physicians with appropriate continuing medical education or training:
- Removal of tattoos or permanent makeup.
- Treatment of vascular changes
- Treatment of pigmented skin changes
- Ablative laser applications
- Applications in which the integrity of the epidermis as a protective barrier is violated
- Applications with optical radiation whose effects are not limited to the skin and its appendages, such as fat tissue reduction
Deadlines
The operator shall notify the competent authority of the operation of the plant no later than two weeks before commissioning. If a plant is already in operation on December 31, 2020, the notification shall be made by the end of March 31, 2021.
Required documents
-
Specialist certificate (from 31.12.2022)
Links to more information
Status: 14.03.2023
Responsible for editing: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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