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LVD Tests of Medical Devices

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.

 

 

LVD Tests for Industrial Devices

Today, many of the enterprises have many industrial devices and equipment purchased from foreign countries that have been used in production for many years and have to continue to use them. The companies that manufacture these machines and equipment guarantee their products for a certain period of time, but after this period, limited service is provided. Because technologies are developing and new or new models are produced every day instead of these industrial devices. Therefore, sub-industrialists generally continue to produce parts of these industrial devices. Subcontracting manufacturers produce suitable solutions with their electrical and electronic infrastructures. However, in this case, security problems arise.

The ability of industrial equipment manufacturers to prove that their products are reliable depends on having electromagnetic compatibility tests (EMC tests) and low voltage tests (LVD tests). These test results prove that the manufactured industrial devices comply with the applicable legal regulations and standards issued by domestic and foreign organizations. Users of these products believe that these products are reliable in terms of human and pet health, property safety and environmental conditions.

The obligation to have LVD tests carried out on industrial devices is in accordance with the Regulation on the Electrical Equipment Designed for Specific Voltage Limits (2016 / 2014 / EU) issued by the Ministry of Science, Industry and Technology in 35. This regulation is based on the low voltage directive 2014 / 35 / EU published in the European Union.

This obligation is not only made in order to prevent domestic consumers from being harmed during the use of industrial devices. More importantly, LVD tests are also important for exporting these products abroad.

Because, according to the European Union directives, it is not possible for products without CE mark to enter and market in European Union countries. The CE marking on these products is based on the fact that manufacturers have LVD tests and receive positive reports. The report prepared after the measurements and tests to be carried out by accredited test and inspection institutions shall be kept by the manufacturer in the technical file for a period of ten years.

Within the scope of LVD tests, mainly insulation tests, high voltage tests, leakage current tests, grounding resistance tests and earth continuity tests are performed for industrial devices.

 

 

Automotive LVD Tests

The fields of electrical and electronic engineering, along with information technologies, are the areas of specialization for today's automotive industry. Thanks to the standardization and modular structure in the fields of electrical and electronic engineering, optimum costs are achieved in production. The automotive sector is the leader in the growth of export and employment figures in our country. The automotive sector is expected to grow with more focus on electricity, electronics and energy in the coming years. Innovation and R & D activities are focused on this subject.

Automotive and automotive sub-industry companies use powerful technologies for safe and controlled automotive production. Increasingly competitive conditions and safety requirements in this sector are forcing companies in this field to achieve lower cycle times and more reliable production.

Large projects are being implemented in automotive main and sub-industries, and many new technologies are used in electrical and electronics. However, on the one hand, the devices, equipment and systems used in the production of vehicles, on the other hand, must not be dangerous in terms of human health and environmental conditions. In order to achieve this, it is important to conduct electromagnetic compatibility (EMC) and low voltage (LVD) tests for the automotive sector. Product and production safety is only ensured by these tests.

Low voltage tests have been made compulsory by the Regulation on Electrical Equipment Designed for Certain Voltage Limits (2014 / 35 / AB) prepared by the Ministry of Science, Industry and Technology on the basis of the 2014 / 35 / AB Low Voltage Directive published in European Union countries. Low voltage (LVD) tests carried out by accredited testing and inspection organizations in the automotive sector, whether the devices, equipment and systems used in the production of vehicles, as well as the vehicles that are completed, are risky in terms of human health and environmental conditions.

LVD tests should also be done to prove the electrical safety of the electrical and electronic components produced in the automotive sector and thus to have CE marking on these parts in order to have free movement in the European Union. The manufacturer must keep the technical file to be included in the certificate of conformity to the standards and the European Union compliance certificate together with the LVD test results for a period of ten years.

 

 

Electrical Meter and Control Cards LVD Tests

Meters that measure the amount of electrical energy produced or consumed, or the work produced and consumed in circuits, are called electricity meters. The more devices or equipment operating on the electrical circuit, ie the more electrical energy is consumed, the faster the pointer on the meter rotates. Electricity meters show the amount of energy consumed in watts / hour.

In the electricity meters, the pointer continuously makes a rotational movement. The speed of this rotational motion is fully proportional to the power of the dissipated electricity. Mechanically, instead of the counter torque, the braking torque is proportional to the speed of the continuously rotating pointer. The braking torque is on a disk which is fixed on the same shaft as the pointer. Therefore, the rotating system with the effect of electric current in these meters deviates by an angle.

Electricity meters are two types, analog and digital. Anolog meters consist of electromagnet, aluminum disc and permanent magnet. The aluminum disc rotates freely between the poles of the electromagnet. Digital meters have electronic circuit elements. These meters have LCD panel, led signal outputs, call button and reset button.

Electricity meters are connected by qualified electricians and sealed by officials. In general, electricity meters are directly connected in low voltage networks, such as in homes or small businesses.

Nowadays, smart meter systems which are designed for home and workplaces and whose features vary according to individuals and businesses are becoming widespread. In this way, more efficient use of energy is ensured while illegal electricity usage is prevented.

In control cards, the system is based on prepaid credit. Consumers get the right to use electricity as much as the loan they receive by paying in advance. In this system, information such as consumption amount, remaining usage right, total consumption amount within a certain time, last power cut error, unauthorized intervention date, last credit loading date and meter type and serial number can be obtained from the meter.

LVD tests are required to ensure safe operation of electrical meters and control cards and to avoid any danger to human health and property safety.

 

 

Ship and Boat Devices LVD Tests

In 2005 by the Ministry of Maritime Affairs Ship Equipment Regulation has been published. This regulation does not apply to new Turkish ships or boats built in our country or in a foreign country, ships registered in the relevant ship registers and international conventions, on all existing Turkish ships and boats, regardless of whether the equipment has been used on the ship or boat and whether or not the ship has been used previously. equipment used.

If the devices used in ships and boats fall within the scope of another regulation which determines their standards, only the principles of this regulation shall be applied in terms of free movement, excluding other provisions.

This regulation has two main purposes:

  • Ensuring the effective implementation of the relevant contracts and other international legal arrangements listed in the annex (Annex A) to be used on ships or boats where ship safety certificates are issued by the official institutions, if necessary, to determine the additional measures to be taken and to observe sea, life, property and environment. ensure safety.
  • To ensure free movement of ship equipment in our country and other countries in accordance with the legal regulations in force and the agreements to which our country is a party.

In the annexes of these regulations, the devices required to be included in ships and boats are detailed in the following basis:

  • Appendix A1 Equipment with detailed test standards in international regulations (rescue equipment, marine pollution prevention equipment, fire protection equipment, navigation equipment and radio communication equipment)
  • Annex A2 Equipment (life-saving equipment, marine pollution prevention equipment, fire protection equipment, navigation equipment and radio communication equipment) without detailed test standards in international rules

All listed devices and equipment are electrical and electronic devices. First of all, electromagnetic compatibility (EMC) and low voltage (LVD) tests are required for correct and error-free operation of these devices, as well as for the safety and health of people and pets in ships and boats.

In addition to these, the CE marking for the free circulation of these devices on the market in European Union and foreign countries depends on the results of these tests.