loader image

Accreditation

attestat

Limited Liability Company “UKRAINIAN INSTITUTE OF STANDARDS” is accredited by NAAU (according to the Technical Regulation on Medical Devices, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 753 and Technical Regulations on Medical Devices 2013 № 754), in the field of:

  • Inactive medical devices
  • Active medical devices that do not implant
  • Products that include use / special substances / technologies
  • Medical devices for in vitro diagnostics
  • Medical devices for in vitro diagnostics
acc_cert_1

LLC UIS has confirmed its competence in carrying out certification work for compliance with the standards of DSTU EN ISO 9001: 2018 “Services in the field of health care and social assistance” and DSTU EN ISO 13485: 2018 “Medical devices. Quality management system. Regulatory requirements in the direction of:

Health and social work services

acc_cert_2.jpg

The scope of activity of the testing laboratory of LLC “UIS” is confirmed by NAAU for compliance with the standards of DSTU ISO / EN 17025: 2017 (ISO / EN 17025: 2017) and applies to testing:

  • Products medical active DSTU EN 60601-1
  • Active medical devices for in-Vitro diagnostics DSTU EN 61010-2-101
  • Active medical devices implanting ISO 14708-1, DSTU EN 60601-1: 2015
  • Medical devices Syringes, needles, catheters, probes and similar articles; ophthalmic and other instruments and appliances, DSTU EN 1618, ISO 7886-1
  • Medical devices Syringes, needles, catheters, probes and similar articles; ophthalmic and other instruments and appliances, DSTU EN 1618, ISO 7886-1

Our experts work only for results

Address
St. Oleksandrivska,
building 1, Kyiv,
Ukraine, 03062
Contacts
+ 38 (050) 818-7-333
office@usi.biz.ua
Order a consultation