Medical Products Laboratory Benchmarks

Medical Product Tests
Medical Product Tests

The medical products sector or the medical devices sector is a sector that continuously develops in parallel with the progress of medicine. For the first time in the eleventh century, Ibn-i Sina was the person who differentiated the concepts of medicine and surgery and who did the surgical operations avoided at that time and developed some surgical hand tools to be used in these operations. Many scientists who followed him invented and developed surgical hand tools. These developments gained momentum with the discovery of electricity, and by the nineteenth century it was a force that triggered progress in medicine. Today, advances in medical devices have reached an unbelievable level thanks to the modern technologies used. Today, America has the largest market share in the world and is followed by European Union countries.

The most recent update of the 2016 Body-Inserted Active Medical Devices Directive provides the following definitions for medical devices:

  • Medical device: When used in humans, they are devices that do not provide the main function with pharmacological, immunological or metabolic effects, but are supported by these effects when used. The objectives of production are:
    • To diagnose, prevent, monitor, treat, or alleviate the disease
    • In order to diagnose, monitor, treat, alleviate or eliminate grievances in the event of injuries or injuries
    • To investigate, alter or replace a anatomical or physiological function
    • To perform birth control

These medical products can be used together or alone. The term cihaz medical devices her includes all tools, tools, hardware, software, accessories and other materials that are required when using these devices for diagnostic or therapeutic purposes.

  • Active medical devices are medical devices that operate on an electrical energy or power source other than the natural structure of the human body.
  • Active implantable medical devices, on the other hand, are active medical devices, some or all of which are implanted in the human body and must remain there.

More than 1,000 products are included in the definition of medical products. Medical products with such a wide range of products can be listed as main headings as follows:

  • All medical imaging systems and devices
  • All devices in operating theaters
  • Respiratory equipment
  • Surgical instruments and devices
  • Prosthetic teeth
  • All kinds of furniture and parts used in medicine, surgery and dentistry
  • Electro-diagnostic equipment and components
  • Dentistry-specific instruments and devices
  • Medical and surgical instruments
  • X-ray devices
  • Artificial joints, prostheses, sound and hearing aids
  • Optical Medical Devices
  • Disposable supplies
  • Radiotherapy systems
  • Physical Therapy Equipment
  • Biochemistry, molecular biology, genetics and microbiology equipment

Only 15 of the medical product need can be met in our country. The introduction of high standards of medical products increases the quality of domestic production. However, the entry of poor quality and low quality medical products into the country harms the domestic industry.

For this reason, it is important to test both the medical products produced and the medical products brought from abroad. Today, some manufacturers operating in our country attract attention with their product quality, increasing reliability in export countries and expanding market shares. In this development which is important for the future of the sector, the benefit of medical product tests and calibration tests performed in accredited laboratories cannot be discussed.

Active medical product tests such as type and process validations in advanced laboratories, packaging products, gloves and similar non-active medical product tests, disinfectant tests such as biological and biocompatibility, many tests for hygiene such as research and development, creation of product, system, environmental and environmental conditions it is performed. In these laboratories, orthopedic products, sphygmomanometers, wheelchairs, patient cots, various consumables and breathing devices are performed many tests.