To ensure the safety of medical electrical equipment and equipment designs, the International Electrotechnical Commission (IEC) has developed the standard IEC 60601 General requirements for medical electrical equipment safety.
This standard describes various test conditions for protection against potential electrical hazards. Routine safety testing of electronic medical devices after commissioning in a hospital or medical facility has traditionally been based on the criteria and limits of this standard.
However, the same organization then published IEC 62353, the standard for repeated testing after the repair of medical electrical equipment.
In this way, the standards that determine the measures to ensure the safety of electromedical devices used in the diagnosis and treatment of patients are harmonized. This new standard defines electromedical devices and processes.
Both standards were published by the Turkish Standards Institute under the following headings:
TS EN 60601-1 Electrical and medical equipment - Part 1: General requirements for basic safety and performance
TS EN 62353 Electrical medical equipment - Retest and test after repair of electrical medical equipment
The IEC 62353 standard focuses particularly on connection safety issues such as earth connection tests, insulation resistance testing, leakage current testing and preventive maintenance.
Meanwhile, the International Standard Organization (ISO) has developed the risk standard for ISO 14971 medical devices. This standard is intended to monitor connection threats, control of these threats and the effectiveness of controls.
In short, it is a standard that helps identify and evaluate threats to medical devices. In our country, it has been published by TSE with the following title: TS EN ISO 14971 Medical devices - Application of risk management to medical devices.
Linked security tests are carried out by advanced laboratories in line with these standards and businesses are supported in terms of eliminating negligible risks, accepting risks and assessing risks and benefits.
The application is received, the contract and then the product, vehicle and vehicles for which, what kind of service is determined exactly.
The necessary laboratory environment is prepared and the products, tools and instruments requested by the organization are tested by experts with the reference of the existing standards and measurements are made.
The data obtained as a result of meticulously completed tests, measurements and analyzes are evaluated and accredited approved reports are submitted by expert engineers.
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