Welcome!

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

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

  • DSTU EN ISO/IEC 17021-1:2015 in the following scope (Certificate):
    • DSTU ISO 9001:2009 (ISO 9001: 2008 IDT) Quality management systems. Requirements;
    • DSTU ISO 9001:2015 (ISO 9001: 2015 IDT) Quality management systems. Requirements;
    • DSTU ISO 22000:2007 Food safety management systems. Requirements for any organizations in the food chain;
    • DSTU ISO 13485:2005 Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2003, IDT);
    • ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes;
    • DSTU EN ISO 13485:2015 Medical devices. Quality management systems. Requirements for regulatory purposes (EN ISO 13485:2012, IDT);
    • EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes.
  • ISO/IEC 17065:2012 in the following scope (Certificate):
    • Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013;
    • Technical Regulations on Medical Devices for In Vitro Diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2013;
    • Technical Regulations on Active Implantable Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 755 dated 02.10.2013.

ECOHYNTOX CAB has been established as a unit of the State Enterprise “L. I. Medvedev’s Research Centre 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. 2Н375 dated 22.05.2015);
  • Research of medical devices, including in accordance with requirements of the series of standards of DSTU ISO 10993:2004 (ISO 10993:1993) Biological evaluation of medical devices, in accordance with the Good Laboratory Practice U.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: 2009 Quality management systems. Requirements (ISO 9001:2008 Quality management systems. Requirements);
    • ISO 9001:2008 Quality management systems – Requirements;
    • DSTU ISO 13485:2005 Medical Devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2003, IDT);
    • ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes;
    • DSTU EN ISO 13485:2015 Medical devices. Quality management systems. Requirements for regulatory purposes (EN ISO 13485:2012, IDT);
    • EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes;
    • DSTU ISO 22000:2007 Food safety management systems. Requirements for any organizations in the food chain.

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.

ECOHYNTOX CAB 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. 121 dated 17.12.2012.

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