Welcome to the website of ECOHYNTOX Conformity Assessment Body of the State Enterprise “L. I. MEDVED’S RESEARCH CENTER OF PREVENTIVE TOXICOLOGY, FOOD AND CHEMICAL SAFETY OF THE MINISTRY OF HEALTH OF UKRAINE” (hereinafter “CAB ECOHYNTOX”)!

CAB ECOHYNTOX has been accredited by the National Accreditation Agency of Ukraine in accordance with the requirements of:

• DSTU EN ISO/IEC 17021-1:2017 (EN ISO/IEC 17021-1:2015, IDT; ISO/IEC 17021-1:2015, IDT) ТА DSTU ISO/TS 22003:2019 (ISO/TS 22003:2013, IDT)in the following scope (Certificate):
  • DSTU ISO 9001:2015 Quality management systems. Requirements (ISO 9001:2015, IDT);
  • ISO 9001:2015 Quality management systems — Requirements;
  • DSTU EN ISO 9001:2018 (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT) Quality management systems. Requirements;
  • DSTU EN ISO 13485:2018 (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT) Medical devices. Quality management systems. Requirements for regulatory purposes;
  • ISO 13485:2016 «Medical devices — Quality management systems — Requirements for regulatory Purposes;
  • ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain;
  • DSTU ISO 22000:2019 Food safety management systems — Requirements for any organization in the food chain (ISO 22000:2018, IDT).

• DSTU EN ISO/IEC 17065:2019 (EN ISO/IEC 17065:2012, IDT; ISO/IEC 17065:2012, IDT)in the following scope (Certificate):
  • Medical Devices.

CAB ECOHYNTOX has been established as a unit of the State Enterprise “L. I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety of the Ministry of Health of Ukraine”, one of the leading research institutions engaged in studying hygiene and toxicology of food products and food raw materials as well as medical devices.

We have necessary technical and intellectual capabilities and authority to ensure performance of the following works:

• Testing of medical devices, including pre-clinical trials, in accordance with requirements of respective technical regulations (Accreditation Certificate No. 20375 );
• Research of medical devices, including in accordance with requirements of the series of standards of DSTU ISO 10993Biological evaluation of medical devices, in accordance with the Good Laboratory Practice S. EPA FIFRA (40 CFR Part 160), Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 and OECD (“Statement of GLP compliance No. G-042” issued by SNAS 09.03.2020). Such research is acknowledged by accredited conformity assessment bodies in thirty-five member states of the OECD.

Applying European approaches and being guided by the impartiality principle in our activity, we offer the following services:

• Assessment of conformity of medical devices to technical regulations;
• Certification of management systems to confirm their conformity to the requirements of:

• • DSTU ISO 9001:2015 Quality management systems. Requirements (ISO 9001:2015, IDT);
  • ISO 9001:2015 Quality management systems — Requirements;
  • DSTU EN ISO 9001:2018 (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT) Quality management systems. Requirements;
  • DSTU EN ISO 13485:2018 (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT) Medical devices. Quality management systems. Requirements for regulatory purposes;
  • ISO 13485:2016 «Medical devices — Quality management systems — Requirements for regulatory Purposes;
  • ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain;
  • DSTU ISO 22000:2019 Food safety management systems — Requirements for any organization in the food chain (ISO 22000:2018, IDT).

N.B.!

Institutions delivering secondary and tertiary health care and claiming the highest accreditation category shall have a certificate of conformity of the quality management system to the requirements of the national standard of DSTU ISO series 9001. Absence of the certificate may be a basis for denial of assignment of the highest accreditation category to the institution.

CAB ECOHYNTOX carries out certification of quality management systems of health care institutions, including primary health care institutions, regardless of their ownership form, in accordance with Resolution of the Cabinet of Ministers of Ukraine No. 765 dated 15.07.1997.