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Certificates and documents for the device PRK-1U

 ABOUT THE DEVICE PRK-1U


RUSSIAN  -  ENGLISH  - GERMAN  -  FRENCH  -  SERBIAN  -  ITALIAN  -  SPANISH  -  PORTUGUESE 


ENGLISH

1. Certificate from the "Idvorsky Laboratories" of compliance of the device PRK-1U with the Electromagnetic Compatibility Regulations  -  READ (EN) / READ (SRB) 

2. Certificate from "Vinča Institute" of compliance of the device PRK-1U with safety requirements  -  READ (EN) / READ (SRB)

3. Certificate of PRK-1U according to ISO 13485:2016 of compliance of medical devices and manufacturing with the requirements of EN ISO 13485  -  READ (EN) / READ (SRB) (about ISO 13485:2016)

4. CE certificate of conformity of PRK-1U with the provisions of the European Union Directive (LVD) (2014/35/EU)  -  READ

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ

5. Certificate of Quality Management System ISO 9001:2015  -  READ (EN) / READ (SRB)  (about ISO 9001:2015)

6. Certificate of the International Standard for Information Security Management System ISO 27001:2013  -  READ (EN) READ (SRB)  (about ISO 27001:2013)

7. Certificate of Energy Management Systems ISO 50001:2018 protecting the environment  -  READ (EN) / READ (SRB)  (about ISO 50001:2018)

8. Certificate of Occupational Health and Safety Management System ISO 45001:2018  -  READ (EN) / READ (SRB)  (about ISO 45001:2018)

9. Certificate of Environmental Management Systems ISO 14001:2015  -  READ (EN) / READ (SRB)  (about ISO 14001:2015)

10. EMC Test Report of  "Idvorski Laboratorije"   -  READ (EN)   /  READ (SRB)

11. Test Report  of  "AN LAB CO"  -  READ

12. The device PRK-1U. Description and methodologies of working with the device (booklet)  -  READ


RUSSIAN

1. Сертификат "Idvorski Laboratorije" о соответствии прибора ПРК-1У правилам электромагнитной совместимости  -  READ (EN) /  READ (SRB)

2. Сертификат "Institute Vincha" о соответствии прибора ПРК-1У требованиям  безопасности  -  READ (EN) /  READ (SRB)

3. Сертификат ПРК-1У по ISO 13485:2016 соответствия медицинских изделий и производств требованиям стандарта EN ISO 13485  -  READ (EN) /  READ (SRB) (подробнее о ISO 13485:2016)

4. Сертификат СЕ о соответствии ПРК-1У положениям Директивы Европейского Союза (LVD) (2014/35/EU)  -  READ (EN)

4.1. Подтверждение технического обоснования выдачи сертификата CE  -  READ (EN)

5. Сертификат качества ISO 9001:2015  -  READ (EN) / READ (SRB)  (подробнее о ISO 9001:2015)

6. Сертификат международного стандарта управления информационной безопасностью ISO 27001:2013  -  READ (EN) /  READ (SRB)  (подробнее о ISO 27001:2013)

7. Сертификат системы энергетического менеджмента ISO 50001:2018 защищающий экологию   -  READ (EN) /  READ (SRB)  (подробнее о ISO 50001:2018)

8. Сертификат системы менеджмента охраны здоровья и обеспечения безопасности труда ISO 45001:2018  -  READ (EN) /  READ (SRB)  (подробнее о ISO 45001:2018)

9. Сертификат системы экологического менеджмента ISO 14001:2015  -  READ (EN) / READ (SRB)  (подробнее о ISO 14001:2015)

10. Протокол тестирования EMC "Idvorski Laboratorije"   -  READ (EN)  /  READ (SRB)

11. Протокол тестирования "AN LAB CO"   -  READ

12. Прибор ПРК-1У. Описание  и методики работы с прибором (брошюра) -  READ


 SERBIAN

1. Sertifikat „Idvorski Laboratorija” o usaglašenosti uređaja PRK-1U sa propisima elektromagnetske kompatibilnosti -  READ

2. Sertifikat „Instituta Vinča” o usaglašenosti uređaja PRK-1U sa zahtevima bezbednosti  -  READ

3. Sertifikat PRK-1U prema ISO 13485:2016 o usaglašenosti medicinskih uređaja i proizvodnje sa zahtevima standarda EN ISO 13485  -  READ (opširnije o ISO 13485:2016)

4. Sertifikat CE o usaglašenosti PRK-1U sa odredbama Direktive Evropske unije (LVD) (2014/35/EU)  -  READ (EN)

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ (EN)

5. Sertifikat za Sistem menadžmenta kvalitetom ISO 9001:2015  -  READ (opširnije o ISO 9001:2015)

6. Sertifikat međunarodnog standarda za Sistem menadžmenta bezbednošću informacija ISO 27001:2013  -  READ (opširnije o ISO 27001:2013)

7. Sertifikat za Sistem menadžmenta energijom ISO 50001:2018 sa zaštitom životne sredine  -  READ  (opširnije o ISO 50001:2018)

8. Sertifikat za Sistem menadžmenta bezbednošću i zdravljem na radu ISO 45001:2018  -  READ (opširnije o ISO 45001:2018)

9. Sertifikat za Sistem menadžmenta zaštitom životne sredine ISO 14001:2015  - READ  ( opširnije o ISO 14001:2015)

10. IZVEŠTAJ SA EMC ISPITIVANJA  "Idvorski Laboratorije"   -  READ (EN)  /  READ (SRB)

11. IZVEŠTAJ SA ISPITIVANJA "AN LAB CO"  -  READ

12. Uređaj PRK-1U. Opis i metodike rada sa uređajem (brošura) -  READ


 GERMAN

1. Certificate from the "Idvorsky Laboratories" of compliance of the device PRK-1U with the Electromagnetic Compatibility Regulations  -  READ (DE) / READ (SRB) 

2. Certificate from "Vinča Institute" of compliance of the device PRK-1U with safety requirements  -  READ (DE) / READ (SRB)

3. Zertifikat der PRK-1U nach ISO 13485:2016 über die Konformität von Medizinprodukten und deren Herstellung mit den Anforderungen der EN ISO 13485  -  READ (EN) / READ (SRB) (Lesen Sie mehr über ISO 13485:2016)

4. CE certificate of conformity of PRK-1U with the provisions of the European Union Directive (LVD) (2014/35/EU)  -  READ (EN)

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ (EN)

5. Zertifikat für Qualitätsmanagementsysteme ISO 9001:2015  -  READ (EN) / READ (SRB) (Lesen Sie mehr über ISO 9001:2015)

6. Zertifikat für Managementsysteme für Informationssicherheit ISO 27001:2013  -  READ (EN) READ (SRB) (Lesen Sie mehr über ISO 27001:2013)

7. Zertifikat für Energiemanagementsysteme ISO 50001: 2018 protecting the environment  -  READ (EN) / READ (SRB) (Lesen Sie mehr über ISO 50001:2018)

8. Zertifikat für Arbeitsschutzmanagementsysteme ISO 45001:2018  -  READ (EN) / READ (SRB) ( Lesen Sie mehr über ISO 45001:2018)

9. Zertifikat für Umweltmanagementsysteme ISO 14001:2015  -  READ (EN) / READ (SRB) ( Lesen Sie mehr über ISO 14001:2015)

10. EMC Test Report  of  "Idvorski Laboratorije"  -  READ (EN)  /  READ (SRB)

11. Test Report  of "AN LAB CO"  -  READ

12. The device PRK-1U. Description and methodologies of working with the device (booklet)  -  READ (EN)


FRENCH

1. Certificate from the "Idvorsky Laboratories" of compliance of the device PRK-1U with the Electromagnetic Compatibility Regulations  -  READ (FR) / READ (SRB) 

2. Certificate from "Vinča Institute" of compliance of the device PRK-1U with safety requirements  -  READ (FR) / READ (SRB)

3. Certificate of PRK-1U according to ISO 13485:2016 of compliance of medical devices and manufacturing with the requirements of EN ISO 13485  -  READ (FR) / READ (SRB) (à propos du ISO ISO 13485:2016)

4. CE certificate of conformity of PRK-1U with the provisions of the European Union Directive (LVD) (2014/35/EU)  -  READ (FR) / READ (EN)

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ (EN)

5. Certificat de Systèmes de management de la qualité ISO 9001:2015  -  READ (FR) / READ (SRB)  (à propos du ISO 9001:2015)

6. Certificat de Systemes de management de la securite de l’information ISO 27001:2013  -  READ (FR) READ (SRB)  (à propos du ISO 27001:2013)

7. Certificat de Systèmes de management de l'énergie ISO 50001: 2018  -  READ (FR) / READ (SRB) (à propos du ISO 50001:2018)

8. Certificat de Systèmes de management de la santé et de la sécurité au travail ISO 45001:2018  -  READ (EN) / READ (SRB)  (à propos du ISO 45001:2018)

9. Certificat de Systèmes de management environnemental ISO 14001:2015  -  READ (EN) / READ (SRB)  (à propos du ISO 14001:2015)

10. EMC Test Report  of  "Idvorski Laboratorije"   -  READ (FR)  /  READ (EN)  /  READ (SRB)

11. Test Report of  "AN LAB CO"  -  READ

12. The device PRK-1U. Description and methodologies of working with the device (booklet)  -  READ (FR)


ITALIAN 

1. Certificate from the "Idvorsky Laboratories" of compliance of the device PRK-1U with the Electromagnetic Compatibility Regulations  -  READ (IT) / READ (SRB) 

2. Certificate from "Vinča Institute" of compliance of the device PRK-1U with safety requirements  -  READ (IT) / READ (SRB)

3. Certificato di PRK-1U secondo ISO 13485:2016 di conformità dei dispositivi medici e produzione con i requisiti della norma EN ISO 13485  -  READ (EN) / READ (SRB) (leggi di più su ISO 13485:2016)

4. CE certificate of conformity of PRK-1U with the provisions of the European Union Directive (LVD) (2014/35/EU)  -  READ (EN)

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ (EN)

5. Certificato del sistema di gestione della qualità ISO 9001:2015  -  READ (EN) / READ (SRB) (leggi di più su ISO 9001:2015)

6. Certificato dello standard internazionale per il sistema di gestione della sicurezza delle informazioni ISO 27001:2013  -  READ (EN) READ (SRB) (leggi di più su ISO 27001:2013)

7. Certificato di Sistemi di gestione dell'energia ISO 50001: 2018 protecting the environment  -  READ (EN) / READ (SRB)  (leggi di più su ISO 50001:2018)

8. Certificato del sistema di gestione della salute e sicurezza sul lavoro ISO 45001:2018  -  READ (EN) / READ (SRB) (leggi di più su ISO 45001:2018)

9. Certificato di Sistemi di gestione ambientale ISO 14001:2015  -  READ (EN) / READ (SRB) (leggi di più su ISO 14001:2015)

10. EMC Test Report of  "Idvorski Laboratorije"   -  READ (EN)   /  READ (SRB)

11. Test Report  of  "AN LAB CO"  -  READ

12. The device PRK-1U. Description and methodologies of working with the device (booklet)  -  READ (IT)


SPANISH 

1. Certificate from the "Idvorsky Laboratories" of compliance of the device PRK-1U with the Electromagnetic Compatibility Regulations  -  READ (ESP) / READ (SRB) 

2. Certificate from "Vinča Institute" of compliance of the device PRK-1U with safety requirements  -  READ (ESP) / READ (SRB)

3. Certificado de PRK-1U según ISO 13485: 2016 de conformidad de productos sanitarios y fabricación con los requisitos de EN ISO 13485  -  READ (EN) / READ (SRB) (leer más sobre ISO 13485:2016)

4. CE certificate of conformity of PRK-1U with the provisions of the European Union Directive (LVD) (2014/35/EU)  -  READ (EN)

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ (EN)

5. Certificado de Sistemas de gestión de la calidad ISO 9001:2015  -  READ (EN) / READ (SRB) (leer más sobre ISO 9001:2015)

6. Certificado de Sistemas de gestión de seguridad de la información ISO 27001:2013  -  READ (EN) READ (SRB) (leer más sobre ISO 27001:2013)

7. Certificado de Sistemas de gestión de la energía ISO 50001: 2018 protecting the environment  -  READ (EN) / READ (SRB) (leer más sobre ISO 50001:2018)

8. Certificado de Sistemas de gestión de la seguridad y salud en el trabajo ISO 45001:2018  -  READ (EN) / READ (SRB) (leer más sobre ISO 45001:2018)

9. Certificado de sistemas de gestión ambiental ISO 14001:2015  -  READ (EN) / READ (SRB) (leer más sobre ISO 14001:2015)

10. EMC Test Report of  "Idvorski Laboratorije"   -  READ (EN)   /  READ (SRB)

11. Test Report  of  "AN LAB CO"  -  READ

12. The device PRK-1U. Description and methodologies of working with the device (booklet)  -  READ (ESP)


 PORTUGUESE

1. Certificate from the "Idvorsky Laboratories" of compliance of the device PRK-1U with the Electromagnetic Compatibility Regulations  -  READ (PORT) / READ (SRB) 

2. Certificate from "Vinča Institute" of compliance of the device PRK-1U with safety requirements  -  READ (PORT) / READ (SRB)

3. Certificado PRK-1U de acordo com ISO 13485: 2016 de conformidade de dispositivos médicos e fabricação com os requisitos de EN ISO 13485 -  READ (EN) / READ (SRB) (leia mais sobre ISO 13485:2016)

4. CE certificate of conformity of PRK-1U with the provisions of the European Union Directive (LVD) (2014/35/EU)  -  READ (EN)

4.1. Confirmation of the technical justification for the issuance of CE certificate  -  READ (EN)

5. Certificate of Quality Management System ISO 9001:2015  -  READ (EN) / READ (SRB) (leia mais sobre ISO 9001:2015)

6. Certificate of the International Standard for Information Security Management System ISO 27001:2013  -  READ (EN) READ (SRB) (leia mais sobre ISO 27001:2013) 

7. Certificate of Energy Management Systems ISO 50001: 2018 protecting the environment  -  READ (EN) / READ (SRB) (leia mais sobre ISO 50001:2018)

8. Certificate of Occupational Health and Safety Management System ISO 45001:2018  -  READ (EN) / READ (SRB) (leia mais sobre ISO 45001:2018)

9. Certificate of Environmental Management Systems ISO 14001:2015  -  READ (EN) / READ (SRB) (leia mais sobre ISO 14001:2015)

10. EMC Test Report of  "Idvorski Laboratorije"   -  READ (EN)   /  READ (SRB)

11. Test Report  of  "AN LAB CO"  -  READ

12. The device PRK-1U. Description and methodologies of working with the device (booklet)  -  READ (PORT)


 

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