What about the medical device disinfection verification report?
Medical device disinfection verification report "CCIC Huatongwei" undertakes processing
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For reusable medical devices that need to be sterilized, the manufacturer shall provide at least one confirmed sterilization method, and the process of confirming the sterilization method is the sterilization verification. Sterilization verification is different from the daily sterilization process. It needs to make a comprehensive judgment based on the clinical use, structure, material and other related information of the product. Commonly used verification methods include semi-period method and overkill method.
Medical device disinfection verification report
China Medical Device Testing Corporation《huatongwei》
Verification of sterilization effect
1. The verification method is to maximize the reproduction of the sterilization scene of the actual use of reusable medical devices, which represents the pathogenic microorganisms that they are exposed to during clinical use. The sterilization verification process recommends the verification method of microbial culture. It is recommended to use indirect methods such as biological indicators or chemical indicators for verification.
2. Selection of reference microorganisms Representative microorganisms should be selected according to factors such as the expected use, risk level, resistance of the sterilization process, resistance of the device's own bioburden and other factors for different devices.
3. The selection of the infection site should be based on the actual clinical use and structure of the product. The selection principle of the infection site should be able to simulate the most unfavorable clinical use conditions and be easy to test.
4. The number of recyclable microorganisms on reusable medical devices used for verification of contamination assessment shall not be less than 1×106, and appropriate negative and positive controls shall be specified.
5. Sterilization process confirmation should confirm the sterilization process, and formulate a corresponding plan, and use the challenge process to confirm, to simulate the most unfavorable conditions in the clinical sterilization process.
6. In addition to the microbiological method, the verification of moist heat sterilization should be supplemented by the heat distribution method to confirm that the relevant physical parameters during the sterilization process meet the requirements, such as temperature, pressure, and time.
Tolerance verification
For reusable medical devices that can withstand two or more sterilizations, the number of sterilizations or the period of use should be confirmed, or the method and acceptance criteria for device performance testing after each sterilization should be provided to the user.
other requirements
After the confirmed sterilization method is sterilized, the biological test can be carried out again.