Certificates

VK product series

VK RespiPro

1_RespiPro_White_Respilon

Certificates / Test reports  
  EU Type-Examination Certificate No.: 0200-PPE-08903 version 4 (COVID-19)
Test report on viral filtration efficiency
Test report on the virucidal effect of accelerated copper
  Test report on non-release of accelerated copper particles
Testing of skin irritation and hypersensitivity in accordance with Czech standard EN ISO 10993
Test report in line with the Czech standard ČSN EN ISO 10993 assessing cytotoxicity, skin irritability and sensibilization
EC declaration of Conformity 
Declaration

 

Mandatory certification

EU Type Examination Certificate – Certified by the certification body FORCE in Denmark, which tested the VK RespiPro product and concluded that VK RespiPro is in accordance with the recommendations for use (RFU), i.e., the filtration efficiency complies with the standard for respirators of RFU 02.075, version 4. The respirator is manufactured to protect against the coronavirus disease (COVID-19). As required by the recommendations of the World Health Organization for this specific purpose, the nominal filtration factor of the respirator is the same as the nominal filtration factor of FFP2 defined in EN 149: 2001 + A1: 2009.

EC declaration of Conformity – The declaration of conformity is issued by the manufacturer of the product. It informs about the fact that the product has been assessed to be in conformity with relevant standards and laws, is safe and used in compliance with the listed recommendations, standards, and laws.

 

Additional certification

Test report on viral filtration efficiency – A test report issued by the American institute Nelson Labs which confirms that the filtration efficiency of viruses of the RFT filtration nanofiber membrane used in the VK RespiPro product ranges between 99.7 % up to 99.9 %.

Test report on the virucidal effect of accelerated copper  – Nelson Labs Virucidal screening test – By the testing of accelerated copper, the ability to deactivate viruses was confirmed by a renown American laboratory.

Test report on non-release of accelerated copper particles – A test report issued by the Czech Academy of Sciences which confirms the safe use of the product in accordance with standards.

Testing of skin irritation and hypersensitivity in accordance with Czech standard EN ISO 10993 – We have requested a test required by the Czech standard ČSN EN ISO 10993 at the National Institute of Public Health, Testing Laboratory No. 1206 accredited by the Czech Accreditation Institute, at the Centre of Toxicology and Public Health. The test showed that our product VK RespiPro did not cause any skin irritation or reaction on faces of volunteers that took part in the testing. By this we can prove that our product is completely safe when in contact with skin.

Test report in line with the Czech standard ČSN EN ISO 10993 assessing cytotoxicity, skin irritability and sensibilization – The National Institute of Public Health in Prague, testing laboratory nr. 1206, certified by the Czech Accreditation Institute, Centre of Toxicology and Health Safety tested VK RespiPro in line with the Czech standard ČSN EN ISO 10993. The tests have shown that VK RespiPro is not cytotoxic, is not a skin irritant and shows no skin sensibilization potential.