It is important that medical devices are safe for human health and do not pose a risk.
The conformity and production of medical devices with the requirements within the framework of the regulation and their placing on the market are performed according to the Medical Devices CE Certificate.
No medical devices without CE certification can be placed on the market.
The manufacturer's tests for medical devices in order to obtain a CE certificate are as follows:
Bioburden Test: The first one of these tests is the Bioburden Test which provides the determination of the microbiological load of the product. Bioburden test determines the microbiological load in the product and determines the level of product sterilization dose accordingly.
Sterility Test: The determination of whether a product is sterile can be determined by the sterility test. Sterility test is carried out to determine whether the dose given in the sterilization process is sufficient for sterilization. The test should be performed in aerobic and anaerobic environments and all microorganisms should be examined.
Stability Test: Shelf life test should be performed on the products to determine whether the products have suffered any deterioration during their shelf life. However, due to the length of this period, accelerated shelf life testing is performed. Accelerated shelf-life test is based on the principle that the product is kept at high temperatures with certain calculations and the shelf life is completed in a shorter time.
Ethylene oxide Residue Test: Ethylene oxide is compatible with most medical instruments and is used for sterilization in many medical products. However, because ethylene oxide has a carcinogenic effect and should be tested against the risk of toxic residue release.
Detergent Residue and Oil-Grease Test:
Especially in products treated with implant-like oil, the oil must be removed from the product. Washing of these products is done. Cleaning validation is required for these products. For the purpose of cleaning validation, oil grease analysis and detergent residue analysis are carried out before and after washing.
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