No one wants to use a diagnostic or therapeutic device that does not measure correctly. Who can rely on measurements and analyzes in a laboratory where faulty measuring devices are used? Incorrect measurement results can create enormous risks to human health. Therefore, the devices used in measurement, test and analysis processes can provide reliable and acceptable measurement results and these can be ensured by conforming to international criteria.
Calibration means reporting the results of a measuring device that is not sure to be accurate compared to another measuring device that is verified for accuracy and has been traceable.
Medical devices in a laboratory or any medical institution must be calibrated to determine that they are in working order and that they are measuring correctly. For this purpose, the control, test and maintenance intervals of the operation of these devices should be determined and the controls performed should be recorded. Especially medical devices used in patient care and treatment must be calibrated.
The relevant legal regulations define what medical devices are. Accordingly, medical devices which have the necessary equipment as specified by the manufacturer and are used on humans for the following purposes are medical devices:
- Devices for the diagnosis, prevention, monitoring, treatment or mitigation of any disease.
- Devices for diagnosing, monitoring, treating or mitigating the effects of any injury or injury.
- Devices for the study, modification or improvement of human anatomy or physiological structure.
- Any device, apparatus or similar device used alone or in combination for the control of pregnancy and which does not achieve its intended use on the human body by pharmacological, immunological or metabolic methods, but makes use of these methods.
New medical devices are manufactured in parallel with technological advances in order to make people sick less, heal faster, last longer and always be healthy and they always give more precise, more accurate and more reliable results than the previous one. However, everything depends on the correct and conscious use of these devices as well as the frequent calibrations.
As far as medical devices are concerned, health companies and employees who use these devices have responsibilities, as well as companies that produce them. Failure to maintain and calibrate medical devices may result in unexpected occupational accidents.
Medical devices must have a calibration label on them. This label must contain the name of the laboratory performing the calibration, the date of calibration and the period of validity. In addition, calibration records must be kept regularly.
The ISO 13485 Medical Devices Quality Management System, designed by the International Standards Organization, was published in 2003. The enterprises that establish and manage this system in their enterprises produce medical devices, both fulfill the requirements of the legal regulations in force and operate in accordance with the relevant standards. In addition, companies who want to put CE marking on their products must make production in accordance with ISO 13485 standard. This standard has been published by TSE in our country as follows: TS EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
Meanwhile, the Ministry of Health has made the following legal regulations on medical devices:
- Medical Device Regulation
- Implementing Regulation on In Vitro Medical Diagnostic Devices
- Implementing Regulation on Active Medical Devices
These regulations mainly regulate the criteria that medical devices should have and the principles for the design, production and inspection of these devices to protect the health and safety of people during their use.
Our company provides medical laboratory services in detail with a strong technological infrastructure and staff.