Things to consider before purchasing radiation-emitting cosmetic devices
Things to consider before purchasing radiation-emitting cosmetic devices
The purchase of a beauty care device requires care, and the radiation safety of the device should be verified before making the purchase decision. The radiation emitted by the device must not exceed the corresponding exposure limits set in the legislation.
The purchase or sale of devices emitting non-ionizing radiation is not subject to a licence. Therefore, it is possible for anyone to acquire, for instance, a powerful medical laser device which may not be used outside healthcare settings in Finland. Typically, the devices intended for beauty care use are marketed as completely safe devices. Instructions for use and product leaflets may suggest that even long-term exposure to radiation does not pose health risks. It should always be kept in mind that the advertising slogans do not guarantee the safety or regulatory compliance of devices.
The purchaser of the device should carefully examine the radiation safety issues related to the device before making a purchase decision. An excessively powerful beauty care device may be banned from use and selling it or getting a refund may prove to be difficult.
The use of powerful treatment devices emitting non-ionizing radiation is only permitted in healthcare settings. In this case, the operator is required to apply for a licence to provide private healthcare services. The regional state administrative agencies and Valvira are the responsible authorities in matters concerning private healthcare licences. The Radiation and Nuclear Safety Authority cannot issue licences that would allow the use of high-powered devices.
It is a good idea to request a declaration of conformity for the device under consideration to be pur-chased. If the declaration of conformity is not available from the manufacturer or the importer, it is advisable not to purchase the device. If the declaration of conformity contains a reference to the standard IEC 60601 or EN 60601 or to a second part of the standard series (e.g. EN 60601-2-5), the device under consideration is a medical device. The standards for medical devices typically do not set an upper limit for the output power, and therefore medical devices often exceed the exposure limit values set in the legislation. When considering the purchase of a medical device, it should be examined whether it is possible to limit the power of the device to a level that does not exceed the exposure limit values.
Should I order a device from an online store?
If you are considering purchasing a cosmetic device emitting non-ionizing radiation from an online store, you should pay particular attention to the level of radiation emitted by the device. For example, as there is no uniform radiation legislation in the EU, purchasing a device which is accepted for use in cosmetic procedures in another EU Member State does not guarantee that the same device may also be used in Finland. In addition, it has emerged that in most cases, foreign manufacturers are not familiar with Finnish national radiation legislation, and the equipment sold have not been adjusted accordingly.
According to the legislation on products, an operator purchasing a treatment device from outside the EU is considered to be the importer of the device. In this case, the purchaser of the device is held liable as an importer for ensuring that the device meets all European requirements and potential specific national requirements. These requirements are not limited to radiation safety of the device. Instead, the importer is also responsible for all other safety aspects relevant to the device such as the electrical safety of the device.
Lasers used in beauty care shall not belong to laser safety class 4 that is defined in the European safety standard EN 60825-1. It is advisable to find out in which laser safety class the device belongs before purchasing it. The laser class should be visible on the nameplate of the device. If the device under consideration is a class 4 laser, it must not be used for cosmetic treatments provided outside healthcare settings.
Class 3B laser devices may also exceed the skin exposure limits set in the legislation. Section 5 of the Radiation and Nuclear Safety Authority's (STUK) regulation on the use of non-ionizing radiation in a cosmetic or other comparable procedure (S/11/2021) includes the conditions under which the use of laser class 3B devices is permitted in beauty care.
The European safety standard EN 60825-1 contains other technical requirements for laser equipment. RF or radio frequency equipment.
RF treatment devices
Radio frequency (RF) radiation is used to direct a large amount of electromagnetic energy to the skin and subcutaneous tissues, which carries the risk of burns. The absorption of RF radiation into the skin and subcutaneous tissues varies depending on skin conductivity, the surface area and the shape of the treatment head, and the frequency of the radiation. If the application of the energy is not controlled properly, more energy than expected may be applied to the tissues resulting in stinging and redness in the mildest cases, and third degree burns in the worst cases. Some of the damage may occur under the epidermis.
Absorption of the RF radiation to the body causes a temperature rise in the tissues. The magnitude of this effect is estimated by the local specific absorption rate (SAR). Unfortunately, this value is not usually defined in the user instructions of the devices, so it must be calculated on a case-by-case basis.
Assessment of the exposure caused by RF treatment devices
The assessment of the exposure caused by cosmetic devices emitting RF radiation requires information on the energy or power produced by the device and the size of the treatment head.
Decree of the Ministry of Social Affairs and Health on limiting the exposure of the general public to non-ionizing radiation (1045/2018) includes the exposure limit values for RF radiation. Exposure limit values are expressed as the specific absorption rate (SAR), a quantity which describes the amount of RF power absorbed by the body. The maximum permissible SAR value is 2 W/kg in the head and body and 4 W/kg in the limbs.
Section 6 of the STUK regulation on the use of non-ionizing radiation in a cosmetic or other comparable procedure (S/11/2021) increases the limit values fivefold compared to the limit values for the exposure of the general public. In this case, the exposure limit values are 10 W/kg (head and body) and 20 W/kg (limbs).
If the exposure limit values in the Decree of the Ministry of Social Affairs and Health are exceeded, the operator is obliged under the Radiation Act to inform the customer of the risks associated with the procedure before performing it. In addition, contraindications related to the treatment procedure shall be available in writing before the device is put into service.
It is not permitted to exceed the limit values of the STUK regulation in treatment procedures. In some cases, a treatment device that exceeds the limit values of the regulation may be brought into line with the regulation by drafting separate treatment instructions. If the safe use of the device cannot be guaranteed despite the treatment instructions, its use is prohibited.
With the reform of radiation legislation in 2018, exposure limit values for ultrasound equipment were introduced. At the same time, ultrasound equipment was granted a five-year transition period until 15 December 2023. After the end of the transition period, the exposure limit values are applied in the monitoring of the use of radiation by STUK and the use of ultrasound devices exceeding the exposure limit values will be permitted only in healthcare settings. Ultrasound devices used outside healthcare which exceed the exposure limit values will be prohibited to be used unless the safety of the treatment procedures can be demonstrated.
The ultrasound intensity and frequency vary greatly depending on the treatment type. Ultrasound may damage blood vessels and the nervous system and cause inflammation and bleeding in tissues.
In high intensity focused ultrasound (HIFU) devices, a small volume is targeted with a large amount of energy, increasing the risk of subcutaneous tissue damage.
Ultrasonic cavitation involves risks related to fetal safety in particular. Strong ultrasound radiation may target the fetus, endangering its health and development. The Ministry of Social Affairs and Health and STUK are of the opinion that ultrasound cavitation should not be performed on pregnant women. The use of ultrasound cavitation also involves other risks, such as the inadvertent application of ultrasound to internal organs or bones, and thus treatment procedures should be left to healthcare professionals.
However, ultrasound devices used for cleaning the skin (so-called ultrasound spatulas) are probably safe to use.
The Decree 1045/2018 of the Ministry of Social Affairs and Health and Annex 3 of the Decree include the ultrasound exposure limit values based on ultrasound intensity, the thermal index and mechanical index. For body parts other than the eyes, the ultrasound intensity should not exceed 0.1 W/cm², and the ultrasound thermal index should be less than 0.7 and the mechanical index should be less than 0.4. The ultrasound intensity applied to the eye shall not exceed 0.05 W/cm², the thermal index shall not exceed 0.7 and the mechanical index shall not exceed 0.2.
Section 7 of the STUK regulation (S/11/2021) allows, under certain additional conditions, the use of higher ultrasound intensity, thermal index and mechanical index in cosmetic procedures when the ultrasound is applied to parts of the body other than the eye. According to the regulation, the ultrasound intensity shall not exceed 3 W/cm², or the ultrasound thermal index should be less than 1.0 and the mechanical index should be less than 0.7. For the eyes, the exposure limit values are in line with the Decree 1045/2018 of the Ministry of Social Affairs and Health.
In other words, treatment devices using ultrasound may be used until 15 December 2023, provided that the procedures performed do not pose a health hazard. If the exposure limit values in the Decree of the Ministry of Social Affairs and Health are exceeded, the operator is obliged under the Radiation Act to inform the customer already during the transition period of the risks associated with the procedure before performing it. In addition, contraindications related to the treatment procedure shall be available in writing before the device is put into service.
During the transition period, STUK recommends that the limit values of the STUK regulation are complied with, particularly if there are doubts about the safety of the procedure.
In beauty care, ultraviolet radiation is mainly used for hardening nail polish and in sunbeds. The exposure limit values for ultraviolet radiation are specified in Appendix 2 of the Decree 1045/2018 of the Ministry of Social Affairs and Health.
Market surveillance carried out at STUK between 2014 and 2015 did not detect nail polish dryers exceeding the limits of the regulation, and they are therefore likely to be safe to use. However, only lamps or light sources specified by the manufacturer as suitable for the dryer shall be used in devices with a replaceable lamp or other replaceable light source.
There is a separate section on the requirements and market surveillance of solarium equipment on STUK's website, which you can access through the links at the end of this page.
With the reform of radiation legislation in 2018, exposure limit values for optical radiation were introduced. At the same time, a five-year transition period until 15 December 2023 was granted for intense pulsed light devices used in cosmetic procedures. After the end of the transition period, the exposure limit values are applied in the monitoring of the use of radiation by STUK and the use of intense pulsed light devices exceeding the exposure limit values will be permitted only in healthcare settings. Intense pulsed light devices used outside healthcare which exceed the exposure limit values will be prohibited to be used unless the safety of the treatment procedures can be demonstrated.
Intense pulsed light (IPL) devices produce a strong light pulse on the skin. According to the Decree 1045/2018 of the Ministry of Social Affairs and Health and Annex 2 of the Decree, the limit value for skin exposure is determined by the equation H = 20,000 t0.25 J/m², i.e. H = 2 t0.25 J/cm², where t is the duration of the light pulse in seconds. For example, when the light pulse duration is 1 ms, the energy density is H = 0.36 J/cm².
According to a STUK estimate, all IPL devices currently in use exceed the exposure limit value of the Decree. However, intense pulsed light devices may still be used until 15 December 2023, provided that no health hazard is caused by the procedures performed using them. If the exposure limit values in the Decree are exceeded, the operator is obliged under the Radiation Act to inform the customer already during the transition period of the risks associated with the procedure before performing it. In addition, contraindications related to the treatment procedure shall be available in writing before the device is put into service and taken into account before performing the treatment procedures.
In addition to IPL, other abbreviations such as SHR, ILS or E-light are sometimes used in the marketing of intense pulsed light devices. However, the operation of the devices is based on the use of light pulses and, therefore, they are also subject to the same exposure limit values.
According to the Decree 1045/2018 of the Ministry of Social Affairs and Health and Annex 2 of the De-cree, the limit value for skin exposure due to infrared radiation is determined by the equation H = 20 000 t-0.25 J/m², where t is the duration of the exposure in seconds. For example, when the exposure time is 10 s, the energy density is H = 35,600 J/m².