Sterile rapid detection system of medical equipment and application method thereof

A technology for medical devices and detectors, applied in the field of medical device sterility rapid inspection systems, can solve the problems of strong subjectivity, difficult judgment, false positives, etc., to reduce subjective judgment errors, shorten the detection period, and reduce the use time. Effect

Pending Publication Date: 2019-02-05
山东省医疗器械产品质量检验中心 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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 addi

Method used

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  • Sterile rapid detection system of medical equipment and application method thereof
  • Sterile rapid detection system of medical equipment and application method thereof
  • Sterile rapid detection system of medical equipment and application method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Such as figure 1 , 2 shown.

[0055] A medical device sterility rapid inspection system, comprising: an automatic tester for sterility test and a culture bottle, the culture bottle is used to contain culture medium and sterilized biological indicator bacteria, and the culture bottle is used to be placed in the sterility test In the automatic detector, the automatic detector for sterility test carries out vibrating culture to the culture bottle;

[0056] The sterility test automatic detector also includes a vibration part, a temperature control part, and a detection part; the vibration part, the temperature control part and the detection part are connected to the MCU chip respectively;

[0057] The vibrating part is used for vibrating the culture bottle;

[0058] The temperature control part is used to control the temperature of cultivation;

[0059] The detection part is used for real-time absorbance detection, pH value detection,

[0060] Metabolic end product CO ...

Embodiment 2

[0068] Such as Figure 4 , 5 shown.

[0069] The culture bottle suitable for the system described in embodiment 1 includes a transparent bottle body 1, a bottle cap 2 is arranged on the upper end of the transparent bottle body 1, and the bottle cap 2 and the transparent bottle body 1 are connected by threads; The bottom of the bottle body 1 is provided with a silicone membrane ring 3, the cross section of the silicone membrane ring 3 is a semi-closed shape, and the silicone membrane ring and the bottom of the transparent bottle form a closed annular area. A detection reagent 4 is set in the area.

[0070] The silica gel diaphragm is a polymer semipermeable membrane. The polymer semipermeable membrane allows CO 2 permeable membrane, and the detection reagent is a pH value chromogenic method value chromogenic reagent. CO 2 Permeable through the silica gel membrane, when microorganisms grow in the culture bottle, the released CO 2 After permeating to the silica gel membran...

Embodiment 3

[0075] Such as image 3 shown.

[0076] A medical device aseptic rapid inspection system as described in Example 1, the difference is that the system also includes a data transmission module: used to collect various types of sterility inspection data in real time, and transmit the inspection data to the outside of the system The storage server; the system also includes a display, the display is used to display the test data or the experimental chart formed corresponding to the processed test data, and the display is connected to the storage server.

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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...

Claims

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Application Information

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IPC IPC(8): C12M1/38C12M1/34C12M1/24C12M1/00
CPCC12M23/08C12M23/22C12M23/38C12M33/14C12M41/12C12M41/34
Inventor 郝树彬王文庆栾同青张萌萌崔璟宋新华
Owner 山东省医疗器械产品质量检验中心
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