Information for professionals in the beauty care industry
In beauty care services that use radiation, the maximum exposure caused to the customer is limited by the exposure limit values. The exposure limit value refers to the maximum amount of radiation that can be applied to the customer’s body. It is the responsibility of the service provider to ensure that the customer is not subjected to radiation exceeding the exposure limit value. Care must therefore be taken when purchasing a beauty care device and the restrictions imposed on its use must be checked before the final decision to purchase is taken.
In most cases, radiation exposure is directly related to the output power of the device and the duration of the exposure. The use of beauty care equipment that exceeds the limits, i.e. is capable of producing very high levels of radiation power or energy, is only permitted in the healthcare units. The Radiation and Nuclear Safety Authority (STUK) monitors the use of radiation outside healthcare units and may restrict or ban the use of devices that are found to be excessively powerful.
In Finland, beauty care equipment must comply with the legal requirements regarding the radiation exposure limits for the general public. The exposure limit values are laid down in Decree 1045/2018 of the Ministry of Social Affairs and Health and in the STUK regulation S/11/2024. The are only few exceptions that allow the exposure limit values to be exceeded during cosmetic treatments.
The purchase or sale of beauty care equipment is not subject to authorization nor does it require a permit, so anyone can freely purchase even the most powerful equipment available. The restrictions apply to the use of the equipment rather than to its possession, purchase or sale. Therefore, it is not unlawful for a manufacturer or seller of equipment to sell to a beautician a device that the latter is not allowed to use. Instead, the service provider, i.e. the purchaser of the equipment, must be aware of the requirements for the use of radiation and purchase the appropriate equipment.
As a purchaser of equipment, you should be also aware that beauty care devices are virtually always marketed as safe, even if they have a very high radiation output. Instructions for use and brochures may suggest that there is no risk to health from the exposure to radiation. However, advertising claims do not guarantee that devices are safe or compliant with the requirements.
A contraindication is a disease or other condition that is a reason not to perform a treatment because of safety concerns. Other conditions may include pregnancy or a device implanted in the body.
The service provider must ensure that the contraindications to the use of the device are defined in writing before the device is commissioned. Usually, contraindications are defined by the device manufacturer and can typically be found in the device's instructions or user manual.
In addition to defining the contraindications, the service provider is required to inform the clients about the contraindications and any risks associated with the treatments before they are carried out. This information can be provided verbally, but it is advisable to provide it in writing so that it can be easily verified later in the event of a dispute. Even if information about contraindications is provided, the responsibility for the safety of the treatments does not shift from the service provider to the customer.
The definition and communication of contraindications is not mandatory in the case of very low-powered beauty care devices. However, if contraindications are defined and available for the device, they should be considered. Informing the clients about them is also highly recommended.
When considering the purchase of a beauty care device based on the use of non-ionizing radiation from an online shop, you should pay close attention to the radiation produced by the device.
There is no uniform legislation regarding the use of radiation in beauty care in the European Union (EU), so the fact that a device may be used in another EU country does not in any way guarantee that the same device can be used in Finland. It has also become apparent that foreign manufacturers and sellers of equipment are not usually familiar with Finnish legislation and may offer devices that do not comply with the Finnish requirements.
An operator who buys a treatment device from outside the EU (e.g. China, USA) will become the importer of the device under the product legislation. In this case, the purchaser of the device also has the responsibility of the importer to ensure that the device meets all European requirements and any specific national requirements. The compliance requirement is not limited to the radiation emitted by the device; the importer is also responsible, for example, for the electrical safety of the device.
Available standards for beauty care devices
It is advisable for the purchaser to ask for an EU declaration of conformity for the equipment they are considering to purchase. The declaration lists the standards with which the manufacturer claims the device complies. If the manufacturer or importer does not or cannot provide a declaration of conformity, it is advisable not to purchase the device.
Unfortunately, there are currently very few published device standards for beauty care devices that would automatically allow the use of the device if their requirements are met. However, there is EN 60335-2-113 for laser and intense pulsed light equipment and EN 60335-2-115 for radio frequency and ultrasound equipment, which set safety requirements regarding the radiation exposure caused by the equipment. Therefore, if one of these standards is mentioned in the declaration of conformity, the use of the device in beauty treatment is allowed, even if the exposure limit values of the legislation are exceeded.
Laser equipment is also covered by standard EN 60825-1, which should be mentioned in the declaration of conformity of every laser device. However, EN 60825-1 does not set any limits on the exposure caused by the equipment. Therefore, compliance with the requirements of the standard does not guarantee that the use of laser equipment is allowed in beauty care services. Laser equipment used in beauty care must not belong to laser safety class 4 as defined in the standard. The use of class 4 laser equipment in skin treatment is allowed only in healthcare units. For Class 1C and Class 3B lasers, it must be verified on a case-by-case basis that their use is allowed in beauty care.
If the EN 60601 series of standards is mentioned in the declaration of conformity, the device is a medical device. Medical device standards typically do not specify an upper limit for the radiation power or intensity, so the devices often exceed the exposure limits. When considering the purchase of a medical device, it is important to determine whether it is possible to adjust the power of the device to a level that does not exceed the exposure limits concerning treatments in beauty care.
There are no formal qualification requirements for the use of beauty care equipment. However, it is obviously essential to receive adequate training and guidance on how to use the device safely. However, even comprehensive training is not in itself an acceptable reason for exceeding the exposure limit values during the treatments.
STUK monitors the use of radiation in beauty care. The subject of the monitoring is the service provider, who may not have in-depth knowledge of the technical characteristics of the equipment. The use of radiation is primarily monitored based on the technical documentation available for the beauty care devices being used.
At the end of this page, you will find a link to the main content of the request for clarification for service providers on the use of radiation regarding the information to be requested about the equipment. To demonstrate the compliance of the equipment, it is recommended that the equipment manufacturer, importer or vendor compiles as comprehensive a documentation as possible of the technical characteristics mentioned in the request for clarification, which the service provider can provide to STUK on request.
Beauty salons do not necessarily advertise prominently what devices are used in the treatments. Therefore, STUK may issue requests for clarifications to different service providers regarding the same model of a beauty care device. Typically, STUK's requests for clarification will result in the service provider contacting the seller or importer of the equipment if the information requested is not readily available. Pre-compiled documentation would probably reduce these unnecessary contacts as well.
The use of high-intensity devices exceeding the exposure limits allowed for cosmetic procedures is permitted only in healthcare units. To operate as a healthcare unit, the service provider is required to apply for a license to provide private healthcare services. The authorities responsible for licensing private healthcare services are the Regional State Administrative Agencies (AVI) and the National Supervisory Authority for Welfare and Health (Valvira).