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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)

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)

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

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

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

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

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

11. 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)

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)

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

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

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

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

10. Протокол тестирования "AN LAB CO"   -  READ

11. 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

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

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

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

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

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

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

11. 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. 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)

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)

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

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

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

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

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

11. 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)

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

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

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

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

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

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

11. 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. 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)

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)

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

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

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

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

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

11. 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. 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)

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)

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

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

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

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

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

11. 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. 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)

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)

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

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

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

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

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

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


 

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