Medical Device Tests

Medical Device Tests

Products produced or offered to markets in the European Union countries generally enter free circulation. The directives in force are:

  • 93 / 42 / EEC Medical Devices Directive
  • 90 / 385 / EEC Active Implantable Medical Devices Directive
  • 98 / 79 / EC Regulation on Medical Diagnostic Devices Used Outside the Body (IVDD)

In general, a product, process, service or system to determine whether certain conditions have been fulfilled is called conformity assessment. Organizations that conduct such conformity assessment activities, including testing, certification, inspection and calibration services, are called conformity assessment bodies.

The conformity assessment bodies that are assigned by the competent authority to carry out the conformity assessment activities in line with the relevant legal regulations and the principles explained in the technical regulations are called notified bodies. The names of the notified bodies are notified to the European Commission and published here.

Standards are texts published by a domestic or foreign standardization organization aiming at the establishment of the most appropriate order under the current conditions, regulating the product characteristics, qualifications or production methods or related terminology, marking, packaging, labeling or conformity assessment procedures and not compulsory.

The infrastructure created to support the reliability and validity of the studies carried out by conformity assessment bodies and issued conformity assessment documents, namely test and inspection reports, management system documents, product documents and calibration certificates is called accreditation. TURKAK (Turkish Accreditation Agency) was established in 2001 in Turkey.

Laboratories are organizations that carry out conformity assessment studies by providing test and analysis services. The conformity of any product (including medical devices) to established standards can be determined at the end of testing and research in an accredited testing and analysis laboratory. In our country, the importance of laboratory services has increased in recent years.

In order to declare that medical devices meet the mandatory requirements described in the relevant legal regulations, it is necessary to test and verify that they comply with the standards set for these medical devices. However, these tests should also be performed in accredited laboratories with proven competence and competence. These laboratories are accredited in accordance with the general requirements standard of TS EN ISO / IEC 17025: 2017 for the competence of test and calibration laboratories.

The main tests for medical devices in laboratories are:

  • Biocompatibility tests
    • In vitro cytotoxicity tests (TS EN ISO 10993-5)
    • Tests for irritation and skin sensitivity (TS EN ISO 10993-10)
    • Systemic toxicity tests (TS EN ISO 10993-11)
    • Genetoxicity and carcinogenicity tests (TS EN ISO 10993-3)
    • Local impact tests after implantation (TS EN ISO 10993-6)
  • Microbiological and chemical tests
    • Ethylene oxide sterilization residue tests (TS EN ISO 10993-7)
    • Sterilization tests (TS EN ISO 11737-2)
    • Clean room and microbiological tests (TS EN ISO 14698)
    • Clean room physical tests (TS EN ISO 14644)
    • Biological load tests (TS EN ISO 11197)
    • Disinfectant tests (TS EN 14561, 14562, 14476)

In line with the evolving needs, the medical device market is also growing rapidly. However, in order to be competitive in all foreign countries, especially in the European Union countries, it is very important that these medical devices are manufactured in accordance with domestic and foreign legal regulations and related standards. In this regard, accredited laboratories have great responsibility.

In the meantime, companies that want to provide free circulation of medical devices produced in our country and marketed in foreign countries should establish ISO 13485 Medical Devices Quality Management System in their enterprises.

Our company performs medical device tests in detail with a strong technological infrastructure and staff.