Sterile rapid detection system of medical equipment and application method thereof

Abstract

The invention relates to a sterile rapid detection system of medical equipment. The sterile rapid detection system comprises an automatic detector for sterile test and a culture bottle, wherein the culture bottle is used for holding a culture medium and a sterilized biological indication bacteria tablet, the culture bottle is used for being arranged in the automatic detector for the sterile test,and the automatic detector for the sterile test is used for performing vibration culture on the culture bottle; the automatic detector for the sterile test also comprises a vibration part, a temperature control part and a detection part; and the vibration part, the temperature control part and the detection part are respectively connected with an MCU chip. The sterile rapid detection system can realize the automatic and rapid sterile monitoring of the medical equipment and the sterilized biological indication bacteria tablet and the like; and compared with the conventional detection means suchas an eye observation result in static culture, the detection limit can be improved, the detection period can be greatly shortened, the subjective determination error of the eye observation can be reduced, and the application time of a biochemical culture box can be shortened. At present, the study on the automatic rapid sterile detection technology of a medical equipment product is still in theblank.

Description

technical field [0001] The invention relates to a medical device aseptic rapid inspection system and an application method thereof, belonging to the technical field of medical device detection. Background technique [0002] The sterilization confirmation and sterilization cycle monitoring of most medical devices require the use of biological indicators, and the sterility inspection of biological indicators after sterilization is of great significance for the sterilization of medical devices. When establishing a sterilization dose for sterilization or verifying the routine effectiveness of this dose or product release, a sterility test should be performed on the biological indicator tablet. When the sterility test shows a positive result, although the actual contamination may be brought in by the test environment, personnel operation, etc., it can be suspected that the biological indicator has not been completely killed, so it is necessary to further investigate the steriliza...

AI Technical Summary

Problems solved by technology

When the sterility test shows a positive result, although the actual contamination may be brought in by the test environment, personnel operation, etc., it can be suspected that the biological indicator has not been completely killed, so it is necessary to further investigate the sterilization effectiveness of the sterilization batch. Conduct retrospective surveys to eliminate deviations or redefine sterilization doses

[0003] At present, there are many problems in the conventional method of sterility inspection of sterile biological indicator bacteria tablets. In addition to the required long detection period (generally 7 days), the sterility inspection also has strong subjectivity in visual observation results and is difficult to judge. The quality control is cumbersome, prone to false negative and false positive results, and has high requirements for personnel operations

[0004] In view of the problems of accurate qualitative and inaccurate detection in the existing technology, those skilled in the art began to develop and research new monitoring equipment to know the sterilization status of the medical device to be tested in time

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