Useful information for manufacturers and importers of beauty care equipment
Treatment devices and their use in beauty care must meet the requirements of national legislation. There is no uniform radiation legislation in the EU. Neither are there standards available for all beauty care device types to demonstrate compliance.
There is no uniform radiation legislation in the EU
As there is no uniform radiation legislation in the European Union (EU), local authorities permitting the use of a treatment device using non-ionizing radiation for beauty care in another EU Member State does not in any way guarantee that the same device may also be used in beauty care in Finland. In addition, it has emerged that in most cases, foreign manufacturers are not familiar with the Finnish radiation legislation, and thus the equipment has not been adjusted accordingly.
In Finland, the use of beauty care devices other than those used in healthcare settings shall meet the requirements of national legislation regarding the exposure limits of the population. The exposure limit values are set in the Decree 1045/2018 of the Ministry of Social Affairs and Health on restricting population exposure to non-ionizing radiation and in the Radiation and Nuclear Safety Authority (STUK) regulation on the use of non-ionizing radiation in a cosmetic or other comparable procedure (S/11/2021).
Exposure exceeding the limit value in cosmetic procedures
According to Section 162 of the Radiation Act (859/2018), in a cosmetic or other comparable procedure carried out outside a healthcare unit as referred to in the Act on the Status and Rights of Patients, the exposure may exceed the limit value if compliance with other requirements set in Section 161 of the Radiation Act can otherwise be ensured.
For example, a clinical trial including a safety evaluation may be considered evidence of compliance with the requirements of Section 161.
Training for the use of devices for beauty care
There are no formal qualification requirements for the use of beauty care devices used in cosmetic pro-cedures. However, it is essential that the user has been adequately trained to use the device. However, even comprehensive training in the use of the device or other instructions are not an acceptable justification for exceeding the exposure limit values of the Decree of the Ministry of Social Affairs and Health or the STUK regulation during the treatment procedures.
Standards for beauty care devices emitting non-ionizing radiation
There are few suitable safety standards for beauty care devices emitting non-ionizing radiation. For the device types for which standards do exist, the radiation safety of a device can be demonstrated by meeting the requirements of these standards in some cases.
For example, exposure to optical radiation may exceed the exposure limit values when using a device which meets the requirements of the SFS-EN 60335-2-113 standard.
Lasers used for beauty care shall not belong to laser safety class 4 as defined in the European safety standard EN 60825-1. The use of class 4 laser equipment is only permitted in healthcare units. The use of class 3B lasers in beauty care is subject to the conditions set in the STUK regulation.
Well-prepared documentation of beauty care devices streamlines the monitoring process
STUK monitors the use of non-ionizing radiation for beauty care outside healthcare settings in Finland. The object of the surveillance is an operator who does not necessarily have in-depth knowledge of the technical characteristics of treatment devices. The monitoring of the use of radiation is primarily carried out based on the technical documents obtained on beauty care devices.
In order to demonstrate the conformity of the devices with the requirements for radiation safety, it is recommended to compile as comprehensive as possible a documentation on the technical properties of the devices. The technical information requested by STUK on the most common types of beauty care equipment can be found at the link at the bottom of the page.
Based on experience, beauty care operators do not necessarily advertise clearly which devices are used for different treatments. For this reason, several different operators may receive requests from STUK to provide information on the same model. Typically, STUK's requests result in the operator contacting the importer of the device if the technical information requested is not readily available.