Notification of installations used on humans for cosmetic or other non-medical purposes.

Installations for the use of non-ionizing radiation on humans for cosmetic or other non-medical purposes must be reported to the competent supervisory authority before commissioning.

Installations with which non-ionising radiation is used for cosmetic or other non-medical applications on humans must be notified to the authority.

With this notification, you can inform the competent authority that you are going to put a plant into operation.

The installations for which this obligation exists are regulated by the "NiSV" ordinance.

Indications as to whether your investment falls under the NiSV can be:

• use for cosmetic purposes in humans;
• human applications that do not serve a medical purpose;
• Applications on humans that are attributed to the "lifestyle", e.g. muscle stimulation, such as assisted training with the help of EMF or similar.

The definitions according to § 2 NiSV specify the performance specifications of the plants. If you do not know them or do not find them in the documents of your system, you should contact your dealer or the manufacturer of your system.

If you have any questions about the notification procedure, please contact the responsible occupational health and safety authority.

The regional council in whose area you want to operate the plant is responsible for your notification.

The regional council in whose area you want to operate the plant is responsible for your notification.

You must send the notification to the authority if you want to operate a plant that falls under the NiSV.

Notifiable devices:

§ 2 Ordinance on Protection against Harmful Effects of Non-Ionizing Radiation for Use on Humans (NiSV)

Duty:

§ 3 paragraph 3 Ordinance on Protection against Harmful Effects of Non-Ionizing Radiation for Use on Humans (NiSV)

You want to operate one or more plants that fall under the provisions of the NiSV:

• Before operating the system, you must report it to the competent authority.
• You must provide information about the system (name, type, type of system, intended use, if applicable).

The authority will check your notification for completeness, compliance with the deadline (at least two weeks before commissioning) and plausibility.

Notification two weeks before commissioning

Existing plants (operation before 31.12.2020) until 31.03.2021

None.

The NiSV does not apply to:

• Plants used for medical purposes on humans (examination, treatment, cure and research)
• Plants that are used non-commercially and do not appear in the context of an economic enterprise (e.g. the use of a privately procured plant on a person in the private environment as part of a courtesy).
• Ultrasonic devices with sound intensities lower than 50 milliwatts per square centimeter at the eye or less than 100 milliwatts per square centimeter at the rest of the body, as well as devices capable of producing a mechanical index not greater than 0.4 or a thermal index greater than 0.7.
• Lasers that do not belong to classes 1C, 2M, 3R, 3B or 4.
• High-frequency devices that do not fall under the provisions of § 2 NiSV.
• Low-frequency devices that do not fall under the provisions of § 2 NiSV.
• DC devices that do not fall under the provisions of §2 NiSV.

Magnetic field devices and magnetic resonance tomographs that do not fall under the provisions of § 2 NiSV.