814.711•Ordinance to the Federal Act on Protection against the Risks associated with Non-Ionising Radiation and with Sound
814.711O-NIRSAFederal Council OrdinanceJun 1, 2019
(O-NIRSA)
of 27 February 2019 (Status as of 31 August 2022)
The Swiss Federal Council,
based on the Federal Act of 16 June 2017 on Protection against Non-Ionising Radiation and Sound1(NIRSA),
ordains:
For the purposes of this Section,solariums means systems, devices and lamps which expose the skin to ultraviolet (UV) radiation.
In the absence of an attendant, solarium operators may only make solariums of UV type 3 available.
For the operation of solariums of UV types 1, 2 and 4, solarium operators must deploy personnel trained in accordance with the following standards2:
The following are prohibited:
For the purposes of this Section:
Laser devices are assigned to Classes 1, 1M, 2, 2M, 3R, 3B and 4 in accordance with SN EN 60825–1:20143,«Safety of laser products – Part 1: Equipment classification and requirements».
The examining bodies shall carry out the examinations, issue the certificates of competence at levels 1 and 2, and keep examination statistics.
The average sound level LAeq1his defined as the A-weighted and equivalent long-term sound level LAeqmeasured over 60 minutes in dB(A).
For the purposes of this Section,laser pointer means a laser device which, on account of its size and weight, can be held in and guided by hand and which emits laser radiation for pointing out objects and locations, for entertainment and for defence or repellent purposes.
The Federal Office for Customs and Border Security (FOCBS)5shall enforce the prohibition on import and transit specified in Article 23 paragraph 1.
This Ordinance comes into force on 1 June 2019.
(Art. 2)
| Solarium UV type | Effective irradiance W/m2 | |
|---|---|---|
| UVB radiation component250 nm < λ ≤ 320 nm | UVA radiation component320 nm < λ ≤ 400 nm | |
| 1 | < 0.0005 | ≥ 0.15 |
| 2 | 0.0005 to 0.15 | ≥ 0.15 |
| 3 | < 0.15 | < 0.15 |
| 4 | ≥ 0.15 | < 0.15 |
The following settings must be available for each specific type of device and be easily adjustable on the device by the users:
| Session series | Session | Irradiation time | Irradiation quantity^12^ | Waiting period before next treatment | % of maximum annual dose^13^ |
|---|---|---|---|---|---|
| 1 | 1stsession with non-tanned skin | Operator indication | max. 100 J/m2 | 48 hours | Operator indication |
| 2ndsession with non-tanned skin | Operator indication min. 10 minutes | max. 250 J/m2 | 48 hours | Operator indication | |
| Following session 1 | Operator indication min. 10 minutes | Operator indication max. 600 J/m2 | 48 hours | Operator indication | |
| Following session 2 | Operator indication min. 10 minutes | Operator indication max. 600 J/m2 | 48 hours | Operator indication | |
| Following session … | Operator indication min. 10 minutes | Operator indication max. 600 J/m2 | 48 hours | Operator indication | |
| Total session series | Max. 3000 J/m2 | Total session 1 | |||
| 2 | Total session series 2 | Max. 3000 J/m2 | Total session 2 | ||
| … | Total session series … | Max. 3000 J/m2 | Total series … | ||
| All session series | Total | Total year max. 25 000 J/m2 |
3.1 Information on the risk groups listed below must be posted in the entrance to the establishment; the information must be easily visible and readable on a DIN A1 size poster and written in the official languages of the relevant canton and in English.
3.2 The risk groups are:
3.2.1 Persons who suffer or have suffered from skin cancer;
3.2.2 Persons with an increased risk of skin cancer, particularly if:
3.2.3 Persons sensitive to UV radiation who:
a. suffer from sunburn,
b. are not able to tan at all or burn easily when exposed to the sun,
c. tend to freckle,
d. have abnormal discoloured patches on the skin,
e. have a natural red hair colour,
f. are being treated for photosensitivity,
g. are receiving photosensitising medications.
4.1 The following information on the dangers and measures must be posted in close proximity to the devices, be easily visible and readable on a DIN A1 size poster and written in the official languages of the relevant canton and in English.
4.2 The operator must inform users that:
4.2.1 UV radiation from solariums can cause irreversible skin or eye damage, such as skin cancer or lens opacity (cataracts);
4.2.2 UV radiation at any age and particularly at an early age increases the risk of skin damage in later life;
4.2.3 after overexposure to UV radiation, the skin may develop sunburn, premature skin aging may occur, and the risk of skin cancer may be increased;
4.2.4 certain medicines may increase UV sensitivity; in the event of any doubt, a physician or a pharmacist can provide advice in this regard;
4.2.5 an interval of at least 48 hours should be left between the first two UV exposure sessions;
4.2.6 if erythema (skin reddening) occurs after the UV exposure, sessions planned in accordance with the UV exposure schedule may be restarted only after one week;
4.2.7 they must not sunbathe and use the solarium on the same day;
4.2.8 when visiting the solarium:
4.2.9 prior to an irradiation session, they should consult a physician if:
a. they have a pronounced sensitivity or an allergic reaction to UV radiation,
b. unexpected effects, such as itching, occur within 48 hours after the first UV exposure session,
c. persistent lumps or sores appear on the skin, or if there are changes in pigmented moles.(Art. 5, 7 para. 2 and 9 para. 2)
The following treatments may only be carried out by persons with a certificate of competence in accordance with Article 5 paragraph 1 letter c or by physicians in accordance with Article 5 paragraph 1 letter a or by their practice personnel in accordance with Article 5 paragraph 1 letter b:
1.1 Treatment of:
1.2 Removal of:
a. hair;
b. permanent make-up by laser treatment, subject to the requirements of Number 2.2;
c. tattoos by laser treatment, subject to the requirements of Number 2.2.
1.3 Laser acupuncture.
2.1 Only physicians qualified in accordance with Article 5 paragraph 1 letter a, or their practice personnel in accordance with Article 5 paragraph 1 letter b, may carry out the following treatments:
m sebaceous gland hyperplasia;
n. varicose and spider veins;
o. vitiligo;
p. warts;
q. xanthelasma.
2.2 Only physicians qualified in accordance with Article 5 paragraph 1 letter a, or their practice personnel in accordance with Article 5 paragraph 1 letter b, may carry out the following treatments on eyelids or close to the eyes (up to 10 mm):
a. removing permanent make-up;
b. removing tattoos and telangiectasia (couperose);
c. treating spider naevi and haemangioma.
2.3 Only physicians qualified in accordance with Article 5 paragraph 1 letter a, or their practice personnel in accordance with Article 5 paragraph 1 letter b, may use the following techniques and processes:
a. highly focused ultrasound;
b. ablative laser;
c. long-pulsed Nd:Yag laser;
d. photodynamic therapies combined with the application of phototoxic substances or medicaments;
e. laser lipolysis.
To obtain the certificate of competence for each treatment according to Number 1, the following knowledge and skills must be acquired:
3.1.1 knowledge of the biological and physiological effects of optical radiation, radiofrequency, cold, shockwaves and ultrasound;
3.1.2 general knowledge of the anatomy, physiology and pathophysiology of human skin and hair, and specific knowledge of changes in skin, vessels, nails and tissue for treatments specified in Annex 2 Number 1;
3.1.3 fundamental knowledge of benign and malignant changes of the skin;
3.1.4 fundamental knowledge of the assessment of skin, hair, vessels, tissue and nails with regard to specific treatments;
3.1.5 recognition of a medical treatment indication and the need for referral to a physician;
3.1.6 knowledge of treatment site preparation and aftercare, hygiene and auxiliaries;
3.1.7 knowledge of the applicable legal provisions; in particular, those treatments which may only be carried out by a physician.
To obtain the certificate of competence for each treatment in accordance with Number 1, the following specifically required technical knowledge from the following list must be acquired: 3.2.1 knowledge of the principles and design of an IPL or laser device, laser classes, risks of reflective surfaces and health risks (eye damage, dazzling); 3.2.2 knowledge of the physical fundamentals of optical radiation, radiofrequency, cold, shockwaves or ultrasound; 3.2.3 knowledge of the technology of the devices that function with optical radiation, radiofrequency, cold, shockwaves or ultrasound; 3.2.4 knowledge of protective measures for operators as well as for clients.
To obtain the certificate of competence for each treatment according to Number 1, the following specifically required technical knowledge from the following list must be acquired: 3.3.1 knowledge of exclusion criteria, possible adverse effects, risks and alternative methods and technologies for the treatments listed in Annex 2 Number 1; 3.3.2 knowledge of the treatment schedule for the treatments listed in Annex 2 Number 1; 3.3.3 knowledge of suitable and unsuitable technologies used for the treatments listed in Annex 2 Number 1; 3.3.4 specific practical experience of the treatments listed in Annex 2 Number 1; 3.3.5 recognition and management of undesirable side effects and complications, in particular recognising those requiring treatment by a physician; 3.3.6. recognition of incorrect settings and equipment defects.(Art. 12–16)
1.1.1 During the scheduled performance of the event or even in the case of malfunction, the laser radiation must not attain the audience area. This requires that the laser device is appropriately positioned or that physical or electronic devices contain or switch off the laser radiation. 1.1.2 Laser radiation must not strike reflective surfaces or objects in an uncontrolled manner. 1.1.3 Laser devices, mirrors and targets must be securely mounted and capable of withstanding shocks, vibrations and wind forces. 1.1.4 Laser radiation must neither endanger performers nor event staff. This requires that the event is appropriately planned, and the persons in question, if necessary, must wear protective glasses or protective clothing. 1.1.5 The laser radiation must not endanger third parties. 1.1.6 Compliance with Numbers 1.1.1–1.1.5 must be successfully tested before the event.
1.2.1 During the scheduled performance of the event as well as in the case of malfunction, the laser radiation that attains the audience area:
1.2.2 Laser radiation must not strike reflective surfaces or objects in an uncontrolled manner.
1.2.3 Laser devices, mirrors and targets must be securely mounted and capable of withstanding shocks, vibrations and wind forces.
1.2.4 The person with a certificate of competence or the person instructed by him/her with a certificate of expertise must ensure visual contact with all laser devices at all times and be able at all times to interrupt the laser event.
1.2.5 Laser radiation must neither endanger performers nor event staff. This requires that the event is appropriately planned, and the persons in question, if necessary, must wear protective glasses or protective clothing.
1.2.6 The laser radiation must not endanger third parties.
1.2.7 Compliance with Numbers 1.2.1–1.2.6 and the emergency procedures must be successfully tested before the event.
Each notification must include the following information: 2.1.1 Details of the organiser: name, address, contact information (telephone number and e-mail address); 2.1.2 Details of the competent person: name, address, contact information (telephone number and e-mail address), certificate of competence or certificate of expertise; 2.1.3 Details of the event: venue, type, date of a single event/dates of series of events, beginning and duration, plan of the event location with marked laser device; 2.1.4 Details for testing the laser device: date and time; 2.1.5 Indication of whether the laser device will project into airspace.
The notification must include the following details in addition to those of Number 2.1: 2.2.1 Confirmation that the event does not involve laser radiation in the audience zone, and that the requirements specified in Annex 3 Number 1.1 will be complied with.
The notification must include the following details in addition to those of Number 2.1:
2.3.1 Specifications for each individual laser device:
2.3.2 Confirmation that the requirements specified in Annex 3 Number 1.2 will be complied with.
Training and examinations shall comprise the following modules:
3.1 Laser technology and safety:
3.2 Health effects:
3.3 Legal foundations:
Explanation of legal foundations, in particular the requirements for:
3.4 Theoretical and practical foundations:
a. Laser show programming,
b. Calculating MPE.
Annex 4^15^
(Art. 20 and 21 para. 1)
1.1 Notifications must include the following information:
1.2 In addition, for events as specified in Article 20 paragraph 1 letter c number 2, a plan of the event venue must be submitted, indicating the location, size and marking of the respite area.
Any person who organises an event involving electroacoustically amplified sound with an average sound level greater than 93 dB(A) and less than or equal to 96 dB(A) must ensure that:
2.1 sound emissions are limited to such an extent that exposures do not exceed the average sound level of 96 dB(A);
2.2 notices are prominently displayed at the entrance to the event, informing the audience of the risk of hearing impairment associated with high sound levels;
2.3 hearing protectors complying with SN EN 352–2:200216,«Hearing protectors – General requirements – Part 2: Ear-plugs»are available free of charge;
2.4 the average sound level is monitored during the event with a sound level meter, as specified in Number 5.2;
2.5 the measuring equipment is operated with the settings specified under Number 5.4.
Any person who organises an event involving electroacoustically amplified sound with an average sound level greater than 96 dB(A) and less than or equal to 100 dB(A) that lasts for no longer than 3 hours must:3.1.1 comply with Numbers 2.2–2.5;3.1.2 ensure that sound emissions are limited to such an extent that exposures do not exceed the average sound level of 100 dB(A).
Any person who organises an event involving electroacoustically amplified sound with an average sound level greater than 96 dB(A) and less than or equal to 100 dB(A) that lasts for more than 3 hours must:
3.2.1 comply with Numbers 2.2–2.5 and 3.1.2;
3.2.2 record the sound level during the whole event in accordance with Number 5.3;
3.2.3 retain the data on the recorded sound level as well as the information in accordance with Number 5.1 on the measurement location, place of determination and level difference for a period of six months, and submit the data when requested by the cantonal enforcement body;
3.2.4 make available to the audience one or more audition respite areas:
Any person who organises an event involving sound that is not electroacoustically amplified with an average sound level greater than 93 dB(A) must:
4.1 inform the audience of the risk of hearing impairment associated with high sound levels;
4.2 make available to the audience, free of charge, hearing protectors complying with SN EN 352–2:2002,«Hearing protectors – General requirements – Part 2: Ear-plugs».
5.1.1 Sound exposures shall be determined at ear level at the point where the audience is exposed to the highest sound levels (determination point).
5.1.2 In the case of measurements made at the determination point, the limit applicable for the event is deemed to be complied with if the reading is less than or equal to the limit.
5.1.3 If the measurement point is not the same as the determination point, the exposures must be corrected accordingly, taking the following into account:
5.2.1 For the cantonal enforcement bodies, the requirements for measuring instruments and for the accuracy classes of sound level meters are based on the FDJP Ordinance of 24 September 201019on Instruments for Sound Measurement.
5.2.2 The measuring instruments of the organisers must be capable of:
The sound level recording must meet the following requirements:
5.3.1 The equivalent continuous sound level averaged over a period of 5 minutes LAeq5minmust be recorded at least every 5 minutes during the event.
5.3.2 The measurement data, together with the exact time of measurement, must be recorded in electronic form.
The measuring equipment used to measure the sound level shall be operated with the following settings:
SR 814.71 ↩
This standard can be consulted free of charge and purchased from the Swiss Association for Standardization, Sulzerallee 70, 8404 Winterthur, www.snv.ch ↩
This standard can be consulted free of charge and purchased from the Swiss Association for Standardization, Sulzerallee 70, 8404 Winterthur, www.snv.ch ↩
This standard can be consulted free of charge and purchased from the Swiss Association for Standardization, Sulzerallee 70, 8404 Winterthur, www.snv.ch ↩
The name of this administrative unit was changed on 1 Jan. 2022 pursuant to Art. 20 para. 2 of the Publications Ordinance of 7 Oct. 2015 (SR 170.512.1 ) (AS 2021 589). This change has been made throughout the text. ↩
SR 172.041.1 ↩
[AS 2007 1307, 2010 4489, 2012 793] ↩
The amendment may be consulted underAS 2019 999. ↩
SR 812.213 ↩
AS 2007 1307, 2010 4489, 2012 793 ↩
AS 2007 1307 ↩
Weighted according to the erythema action spectrum of Standard SN EN 60335-2-27:2013, «Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation». ↩
Weighted with the effect spectrum for non-melanocytic skin cancer SN EN 60335-2-27:2013, of Standard SN EN 60335-2-27:2013,«Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation». ↩
This standard can be consulted free of charge and purchased from the Swiss Association for Standardization, Sulzerallee 70, 8404 Winterthur, www.snv.ch ↩
The correction of31 Aug. 2022 concerns the French text only (AS 2022 478). ↩
This standard can be consulted free of charge and purchased from the Swiss Association for Standardization, Sulzerallee 70, 8404 Winterthur, www.snv.ch ↩
SR 818.311 ↩
This standard, available in English and French, can be purchased from Electrosuisse, Luppmenstrasse 1, CH-8320 Fehraltorf, www.electrosuisse.ch, or consulted free of charge at the Federal Office of Public Health, Schwarzenburgstrasse 157, CH-3097 Liebefeld. ↩
SR 941.210.1 ↩
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