Certification for quality and applicability in healthcare
UV Smart develops disinfection equipment according to strict quality requirements, and substantiates the application with scientific and clinical research; all of this in line with the appropriate norms and standards. Find an overview here.
- Our product meets the ISO norm NEN-EN 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests). This means that the Emergency version, D25 and D60 meet the general safety requirements for medical electrical equipment.
- NEN-EN 14885 is used as a reference for the D25 (Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics). This means that the equipment achieves the same as disinfection wipes and liquid (because there is no guideline for UV-C yet).
- NEN-EN-ISO 15883 is used as a reference for the D60 (Washer-disinfectors – General requirements, terms and definitions and tests).
- UV Smart B.V. carries the NEN-EN-ISO 13485 certificate since June 2020. This is the international standard for medical device manufacturers, suppliers and distributors to demonstrate that they meet the legal requirements regarding medical devices.
- The D25 was granted CE certification (MDD class IIa) on May 6, 2020.
- CE certification has also been requested for the D60 model.
- The emergency version (ECD) falls under CE-exceptionrule of IGJ; This is a temporary arrangement in view of the COVID-19 situation, so that equipment – after registration by the manufacturer – can be used temporarily without a CE certificate.
- Impelux™ is patented technology using UV-C, for guaranteed disinfection without damage to equipment and with validated and continuous effectiveness.