Направления деятельности:
Ру
Medical device testing
Services for conducting technical and toxicological tests, as well as electromagnetic compatibility (EMC) tests, in compliance with the regulations of the Russian Federation and the EAEU, carried out in our own testing centers.
The ElectronTest Testing Center includes the ElectronTest Laboratory, accredited by Rosakkreditatsiya to conduct technical tests of medical devices. In addition, it comprises a clinical diagnostic laboratory (CDL), licensed by Roszdravnadzor to perform clinical diagnostic studies and accredited by the EAEU to conduct clinical laboratory tests required for In Vitro medical device registration.
The testing center is also accredited within the European ILAC system, which ensures that its test protocols, including those for In Vitro products, are recognized when obtaining the European CE safety certificate.
The ElectronTestBio Laboratory is accredited to conduct medical device and pharmaceutical testing to assess biological safety. The laboratory is fully equipped to perform studies within its accreditation scope and operates in purpose-built facilities ensuring optimal research conditions.
It is equipped with advanced measuring instruments and testing devices, and holds a Rospotrebnadzor license for working with microorganisms of pathogenicity groups III and IV.
The laboratory consists of three specialized divisions:
1.
Chemical-Analytical Research – testing of medical devices for physicochemical and sanitary-chemical parameters using methods such as liquid and gas chromatography, and atomic absorption spectrometry;
2.
Microbiological Research – assessment of sterility and microbiological purity of medical devices, bactericidal permeability of masks and medical clothing, and resistance of materials to mold fungi;
3.
Toxicological Research – evaluation of parameters such as irritant effect, pyrogenicity, acute systemic toxicity, cytotoxicity, hemocompatibility, and endotoxin content. These tests are conducted in the laboratory’s own experimental clinic using animal studies.
The ElectronTestEMC Laboratory provides a full range of testing for medical equipment to ensure compliance with electromagnetic compatibility (EMC) requirements.
The laboratory includes three shielded chambers:
The ElectronTestEMC is a testing laboratory whose main activity is testing technical equipment for compliance with electromagnetic compatibility (EMC) requirements.
Accredited by Rosakkreditatsiya, ElectronTestEMC conducts EMC testing not only for medical equipment, but also for a wide range of other equipment requiring conformity assessment, such as automotive systems, measuring instruments, and more.
Large semi-anechoic chamber (10 m test distance) for emission and immunity testing.
1.
Small anechoic chamber (3 m test distance) for testing resistance to electromagnetic fields.
2.
Shielded room (11 m long) for carrying out all types of EMC testing.
3.
The capabilities of the technical equipment of the Electrontests testing laboratory make it possible to conduct EMC tests not only of medical equipment, but also of a wide range of various equipment requiring an assessment of compliance with electromagnetic compatibility requirements. For example: automotive equipment, control and measuring equipment, and so on.
Key Figures
2 200+
Test methods
1 500+
Units of test equipment
45
Units of unique test equipment
