Electromedical Devices

Many years of experience in testing of electromedical products provide fast and efficient services in a modern testing laboratory, with trained staff. Services include:

  • pre-compliance testing
  • services of clarification of the requirements of the standards to the manufacturers, for development of new products
  • services of the final testing for CE marking

Tests are carried out according to the current versions of the Serbian standards, that are identical with the international versions (EN, IEC).

Types of Testing

Laboratory performs products safety testing, concerning electrical and mechanical characteristics, hazards and material testing like:

  • input power and electricity
  • protection against the risk of electric shock (permanent leakage currents, protective grounding, dielectric strength)
  • protection against mechanical hazards
  • protection against ignition of flammable mixtures
  • protection against excessive temperatures
  • precision of working characteristics
  • abnormal operation and fault status
  • constructional requirements

The types of products that can be tested

Electromedical equipment and Electromedical systems

Testing are carried out according to the current version of the standard SRPS EN 60601-1 and its annexes (that are identical with the international EN or IEC versions).

Electromedical device is any electrical equipment that contain parts that in physical contact or in any other manner perform the transfer of energy to and from the patient, that is powered from the electrical power source and has the task to carry out the diagnosis, treatment or monitoring of specific patient conditions.

Electromedical system is specified combination of multiple devices interconnected via functional connections, of which at least one is electromedical.

Dental units

Testing of safety parameters is performed in accordance with the general requirements and test methods regardless of whether the present system has a power supply (according to standard SRPS EN ISO 7494-1) and methods of testing for materials, design and construction of water supply and air within the dental units (according to standard SRPS EN ISO 7494-2).

Sterilizers and Washers and disinfectors used to treat medical materials

Testing of safety parameters of electric devices and equipment that are intended to be sterilized, washing and disinfection of medical materials in medicine, veterinary medicine, the pharmaceutical and other laboratories when used in environmental conditions are carried out according to the requirements of standard IEC 61010-2-040.

PAccording to the current scope of accreditation testing of this types of equipment are carried out in the Laboratory of Metrology.

Risk management of medical devices

Laboratory systematically provides a framework for manufacturers of electromedical equipment using experience, observation and judgment to manage the risks when using medical devices (standard EN ISO 14971). Also, Laboratory collaborates with manufacturers in other industries related to health care.

Useful links

Additional Information

All laboratories of Kvalitet a.d. are accredited by the Accreditation Body of Serbia (ATS).

ATS is a signatory of the multilateral agreement on recognition of accreditation with the European Organization for Accreditation (EA), and also IAF MLA signatory with the International Accreditation Forum (IAF) and the ILAC MRA agreement with the International Laboratory Accreditation Cooperation (ILAC).

Therefore, the reports issued by Kvalitet a.d. Niš are the basis for placing of the CE mark, , as they can be recognized in all the countries whose accreditation bodies are signatories of named agreements, including all European Union countries.