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A clinical trial of a medical device is a specific study conducted to evaluate the functionality and safety of the device being tested. Tests are carried out in special accredited classrooms. After completion of the clinical trial, a protocol is drawn up.
Medical research is carried out in accordance with Order of the Ministry of Health dated January 09, 2014 No. 2n. This order regulates the procedure for conducting clinical trials. Conducts conformity assessment through technical checks as well as toxicological analysis. Such clinical trials are carried out for the purpose of state registration of medical devices within the framework of current legislation.
Technical tests – tests in order to determine the compliance of the characteristics (properties) of a medical device with the requirements of the regulatory, technical and operational documentation of the manufacturer (manufacturer) and make a subsequent decision on the possibility of conducting clinical trials, in accordance with the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On approval of the Rules for state registration of medical products".
Technical tests of a medical device are carried out in accredited testing laboratories that meet established requirements. The manufacturer of a medical device or an authorized representative of the manufacturer (applicant) independently determines the testing organization that carries out technical testing, taking into account the scope of its accreditation.
When carrying out technical tests:
During technical tests:
Electromagnetic compatibility (EMC) — the ability of technical means (TS) to operate with a given quality in a given electromagnetic environment without creating unacceptable electromagnetic interference to other technical means. Vehicles are any devices that use electromagnetic (EM) phenomena. For example: amplification, switching, conversion devices. Electromagnetic interference is any electromagnetic phenomenon that can cause disruption to the operation of a vehicle.
Electromagnetic compatibility is violated if the level of interference is too high or the immunity of the equipment is insufficient. In this case, there may be a disruption in the operation of computers, the issuance of false commands in control and navigation systems, which leads to terrible disasters.
In the EU countries, Directive No. 89/336/EEC “On the harmonization (approximation) of the legislative acts of the Member States of the European Community relating to electromagnetic compatibility” came into force. The Directive applies to equipment capable of causing electromagnetic interference or whose performance is susceptible to such interference. In accordance with this document, since 1996 in Europe, the sale of technical equipment without a certificate of compliance with electromagnetic compatibility standards is not allowed.
In Russia, various electrical and electronic equipment (computers, cash registers, medical equipment, etc.) are subject to mandatory EMC certification. The certificate is issued on the basis of a test report carried out in an accredited laboratory. The tests include checking the vehicle's immunity to interference with standard parameters and checking for permissible levels of generated interference.
Electromagnetic Interference Test Standards
Currently, new domestic standards and test methods (over 50 standards) are being introduced in Russia, harmonized with international and European standards that regulate the scope of modern requirements for technical means to ensure electromagnetic compatibility (EMC). Decisions to improve regulation in the field of EMC were associated, first of all, with the widespread use of microelectronics and computer equipment in the household, industrial and economic spheres.
At the same time, the increasing level of electromagnetic interference was taken into account, including low-frequency and high-frequency interference caused, for example, by mobile phones. The need to remove barriers to international trade was also taken into account.
Interference Immunity Tests:
Emission tests:
Specialists of CPS LLC will help prepare and execute the documents required for product testing.
