Sterility Testing
Sterilization is an important process especially for products and devices used in medical fields. Sterility control is carried out to control the sterilization of products or devices with many test and analysis methods. "Sterility Test" is carried out to check the adequacy of sterilization processes performed on medical products or devices or to control the sterilization method.Medical devices must be sterile. In order to protect human health, sterilization process is carried out in medical products and devices. For this reason, a medical product or device with a microorganism load that may endanger human health cannot be accepted. With the Sterility Test, medical products and devices are evaluated in terms of cleanliness and suitability, and their suitability and adequacy of the sterilization process are evaluated.
According to the Medical Device Regulation, “Sterile medical devices must be manufactured and sterilized by an appropriate and valid method.” For this reason, appropriately produced and sterilized medical products and devices must be tested and approved by accredited and authorized laboratories.
