Electrical and electronic devices are now an integral part of life. A variety of these devices and equipment is used every day. However, as these devices increase their place in daily life, safety problems for human, animal and environmental health are constantly increasing. In order to overcome these problems, low voltage tests (LVD tests) have an important place from the design and development stages of the products to the production and marketing stages.

Some of the electrical and electronic devices are used in medicine. Therefore, medical devices must also undergo LVD tests in order to be safely manufactured and placed on the market.

LVD tests of medical devices are carried out in accredited test and inspection organizations within the framework of the relevant legal regulations and the conditions described in the standards referred to by these regulations. It is important to determine that medical devices and equipment are harmless to electrical and mechanical hazards to humans, animals and the environment and to prove that they are reliable in this respect.

The basis for LVD tests is the Regulation on Electrical Equipment Designed for Specific Voltage Limits (2014 / 35 / EU) issued by the Ministry of Science, Industry and Technology. The purpose of this regulation is to detect the problems related to human, animal, property and environmental safety that may occur in electrical devices before the product is released, to take precautions for possible risks and to eliminate these risks as much as possible. As a result of these tests, certificate of conformity to standards is given by the test institutions. Manufacturers are required to keep this document during the 10 year.

The main standard used in electrical safety testing of medical devices is:

• TS EN 60601-1 Electrical and medical equipment - Part 1: General requirements for basic safety and performance

For the purposes of this standard, medical devices are devices that are electrically connected and allow the patient to be kept under medical supervision, such as diagnosis, treatment or monitoring.

LVD tests for medical devices are also made for the CE marking on these products. Because, firstly, LVD tests must be performed and these products must be proved to be reliable in order to market these devices to European Union countries and other foreign countries.