Numerous standards have been developed for medical devices and several regulations have been adopted to ensure compliance with these standards. In addition, many test methods are applied to determine the conformity with the standards developed by domestic and foreign organizations. These tests can be classified as biocompatibility tests, microbiological tests, chemical tests, electronic and electrical tests and physical tests.

A few examples of these tests are listed below and are based on the following standards:

• Biocompatibility tests in medical devices
• Cytotoxicity test (TS EN ISO 10993-5 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity tests)
• Acute systemic toxicity test (TS EN ISO 10993-11 ... Section 11: Systemic toxicity tests)
• Genotoxicity test (TS EN ISO 10993-3 ... Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity)
• Microbiological tests
• Tests for the determination of ethylene oxide, ethylene hydrochloride, ethylenglycol residues (TS EN ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues)
• Sterilization tests (TS EN ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Sterilization performed in the description, validation and maintenance of a sterilization process
• Clean room physical tests (TS EN ISO 14644 Clean rooms and related controlled environments)
• Endurance tests on gloves (breaking strength before and after accelerated aging, etc.) (TS EN 455 Disposable medical gloves)
• Electronic and electrical tests
• Electromagnetic compatibility tests (TS EN 60601 Medical electrical equipment)
• • Electrical testing (TS EN 60601 standard)
• Physical tests
• Physical and mechanical tests on sphygmomanometers (TS EN 1060 non-invasive sphygmomanometers)
• Physical and mechanical tests on oxygen concentrators (TS EN ISO 80601-2-69 Electrical medical equipment - Part 2-69: Particular specifications for essential safety and required performance of oxygen concentrator equipment)
• Phototherapy equipment (TS EN 60601 Medical electrical equipment)

Physical testing of medical devices includes size control tests. In order to ensure accurate, precise and reliable results of measurement, test and analysis studies, the dimensions of the devices used in these processes must be determined as accurate. Similarly, the size of the devices used in the diagnosis and treatment of diseases and injuries is also important.

It is important that the enterprises producing these devices operate in accordance with the ISO 13485 Medical Devices Quality Management System standard. This standard was published by the International Organization for Standardization (ISO) in 2003. It is based on the ISO 9001 Quality Management System standard and covers additional requirements specifically designed for medical devices. This standard specifies the minimum requirements for enterprises producing medical devices.

The companies that carry out their production in accordance with the ISO 13485 Medical Devices Quality Management System criteria undergo the biocompatibility, microbiological, chemical, electronic and electrical and physical tests described above before presenting the medical products to their customers and proving that they comply with the relevant standards. In this context, it is determined whether the dimensions of all kinds of medical devices used in tests and measurements as well as in diagnosis and treatment comply with the relevant standards.

Essentially, the ISO 13485 standard provides enterprises with significant advantages in providing access to global markets, increasing operational efficiency, reducing costs and monitoring supply chain performance. ISO 13485 Medical Devices Quality Management System enables the enterprise to develop more reliable and more effective medical devices. It also ensures that the enterprises comply with the domestic and foreign legal regulations.

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