Compliance & Safety
of the PRK-1U device
The PRK-1U has passed rigorous electromagnetic compatibility and safety tests, guaranteeing its compliance and safe use.
Le 11 janvier 2021, à la demande de l’avocat A.V. Borodin, un examen scientifique et technique de la conformité de l’appareil PRK-1U with the functions claimed has been carried out.
Au cours des études, il a été constaté que les certificats soumis aux experts correspondent à la documentation réglementaire requise permettant l’utilisation des appareils PRK-1U dans les pays de l’Union européenne.
Certificate of compliance with electromagnetic compatibility standards
The PRK-1U three-mode device has passed electromagnetic compatibility tests in the State laboratory Idvorski Laboratories of theMihailo Pupin Institute (IMP) subordinate to the Serbian Ministry of Science, en pleine conformité avec la directive CEM de l’Union européenne.
The official website of Idvorski Laboratories states the following:
"The legal framework for electromagnetic compatibility in the "single market" of the European Union is defined by the EMC Directive (2004/108/EC) and all equipment or systems placed on the market or in operation must comply with the requirements of harmonised EU standards. The EMC Directive was updated (2014/30/EU) and came into force in 2016. Since 1 January 2012, the EMC Directive has also been mandatory in Serbia."
Consequently, the electromagnetic compatibility tests on the PRK-1U were carried out by Idvorski Laboratories in accordance with the European Union's Electromagnetic Compatibility Directive.
Le certificat de conformité de l’appareil PRK-1U, délivré par Idvorski Laboratories, au sens des directives de l’Union européenne conformément au droit international, permet d’apposer le marquage CE sur l’appareil.
Serbia's Ministry of the Economy has appointed Idvorski Laboratories to issue such certificates for the sale of appliances with these characteristics under European Union directives.
There are therefore no restrictions on the use of PRK-1U devices in the European Union.
The EMC report from the Idvorski laboratories in English on the testing of the PRK-1U 3-mode device, concluding that the characteristics of this device meet European Union standards, is included in printed form in the packaging box containing the device and can be found on the website indicated on the rear panel of the device.
Certificate of compliance with safety requirements
The PRK-1U has undergone a full safety test in the ANL laboratory and received a certificate from Vinča Institute.
The ANL laboratory report en anglais sur les essais du dispositif PRK-1U aboutit à la conclusion que les caractéristiques de ce dispositif sont conformes aux normes de l’Union européenne.
The photo of the CE-marked appliance, which covers the entire appliance connected to a power socket with an adapter, can be found on the first page of the report.
L’étude des documents fournis permet aux experts de conclure que les appareils à trois modes PRK-1U utilisés dans le domaine de l’éducation ne sont pas nocifs pour la santé, conformément aux certificats de la Serbie sur les paramètres normaux de la compatibilité électromagnétique et de la sécurité, sur la base desquels l’appareil est étiqueté AAA CE.
The experts concluded that the PRK-1U three-mode devices correspond to the declared functions.
Information on the inventions on the basis of which the device was created can be found in the registration number marked on the device together with the patent protection numbers: "Patent pending: 2148845; 2163419; 62673151".
CE & ISO certificates
The certificates of compliance obtained on the basis of these reports are given on the website page: Certificates of Compliance PRK-1U in English, Russian, Serbian, German, French, Italian, Spanish and Portuguese.
You can also find all the certificates on this page.
Certificat CE de conformité du PRK-1U aux dispositions de la directive de l’Union européenne (LVD) (2014/35/UE) :
ISO 45001:2018 occupational health and safety management system certificate:
ISO 9001:2015 Quality Management System Certificate:
Certificate of conformity of medical devices and their manufacture to the requirements of standard EN ISO 13485:2016 :
Certificat de conformité à la norme internationale ISO 27001:2013 relative aux systèmes de gestion de la sécurité de l’information :
Certificat de systèmes de gestion de l’énergie ISO 50001: 2018 pour la protection de l’environnement :
ISO 14001:2015 Environmental Management Systems Certificate:
