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A method for testing the liquid bacterial retention capacity of an air filter/membrane for infusion

An air filter and testing method technology, applied in the field of testing, can solve the problems of inaccurate testing, inability to ensure safety, and poor operability, and achieve the effects of ensuring safety, reducing test errors, and simple and convenient testing operations.

Active Publication Date: 2021-08-27
河南省医疗器械检验所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still problems in the existing detection methods: the method is not very operable, lacks test details, the application range is small, and the test is not accurate enough to ensure the safety of use, etc.

Method used

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  • A method for testing the liquid bacterial retention capacity of an air filter/membrane for infusion
  • A method for testing the liquid bacterial retention capacity of an air filter/membrane for infusion
  • A method for testing the liquid bacterial retention capacity of an air filter/membrane for infusion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1 Determine the test pressure value:

[0052] To test the air filter, challenge the direction from the inside to the outside. Such as figure 1 , Figure 4 Shown: The following test operations all took place in biological safety cabinets or ultra-clean workbenches. Unscrew the cover 12b from the bacteria tank 12, inject the challenge bacteria solution into the tank 12a, and tighten the cover 12b. Install the air filter to be tested to the test assembly, and adjust it to the state to be tested, and install the infrared liquid level probe 8c to the corresponding position of the test assembly. Plug in the power plug 13, turn on the power switch 16, and the power indicator light 15 is turned on. Turn on the negative process switch 20, the working indicator light 8b, the negative test channel solenoid valve 8a, the system solenoid valve 19a, and the negative infrared liquid level probe 8c are all automatically turned on, and then the air pump 3 is turned on, an...

Embodiment 2

[0055] Example 2 To test the air filter, the challenge direction is from inside to outside.

[0056] Such as figure 1 , Figure 4 Shown: The following test operations all took place in biological safety cabinets or ultra-clean workbenches. Connect negative test assembly 8, positive test assembly 9, and sample test assembly 10 to the detection device in the following order: control system 1, primary air filter 2, air pump 3, pressure gauge 4, pressure regulator 5, secondary air Filter 6, bacteria tank 12, diverter 7, test assembly. Plug in the power plug 13, turn on the power switch 16, and the power indicator light 15 is turned on.

[0057] Test the negative control sample: unscrew the cover 12b from the bacteria tank 12, pour sterile water into the tank 12a, and tighten the cover 12b. Install the negative control to the negative test component 8, and adjust it to the state to be tested, and install the negative infrared liquid level probe 8c to the corresponding position ...

Embodiment 3

[0060] Example 3 To test the air filter, the challenge direction is from outside to inside.

[0061] Such as figure 2 , Figure 4 Shown: The following test operations all took place in biological safety cabinets or ultra-clean workbenches.

[0062] The following test operations all took place in biological safety cabinets or ultra-clean workbenches. Connect negative test assembly 8, positive test assembly 9, and sample test assembly 10 to the detection device in the following order: control system 1, primary air filter 2, air pump 3, pressure gauge 4, pressure regulator 5, secondary air Filter 6, constant pressure tank 11, splitter 7, test assembly. Plug in the power plug 13, turn on the power switch 16, and the power indicator light 15 is turned on.

[0063] Install the negative control to the negative test component 8, inject a specific volume of sterile water into the negative test component 8; install the positive control sample (liquid) to the positive test component...

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Abstract

The purpose of the present invention is exactly to provide a kind of detection method of transfusion and blood transfusion apparatus to liquid bacteria interception ability, at first install equipment, then carry out according to the following steps: the wetting of air filter / membrane and the residual verification of wetting liquid; challenge bacterial liquid preparation and Confirmation of bacterial liquid state, calculation of challenging bacterial liquid volume; determination of test pressure values ​​under different challenges; different challenge tests and result judgment; the method of the present invention is novel and unique, easy to operate and use, and is used to test nominal 0.22μm air filters / membranes Excellent liquid bacterial interception ability ensures the safety of infusion and blood transfusion equipment, and has significant economic and social benefits.

Description

technical field [0001] The invention relates to a detection method, in particular to a detection method for the liquid bacterial retention capacity of an air filter / membrane used in an infusion and blood transfusion set with a nominal size of 0.22 μm. Background technique [0002] Infusion and blood transfusion are one of the commonly used means of disease treatment at present. Disposable infusion and blood transfusion sets are common medical equipment consumables. They use gravity to establish channels between veins, liquid medicine and blood, which have the advantages of quick onset and small damage. Advantages, easy to be accepted by patients, clinical application is very extensive. Infusion and blood transfusion sets are medical devices with a very large amount of clinical use. According to statistics, the annual consumption of infusion / blood transfusion sets in my country reaches more than 5 billion. [0003] Intravenous infusion and blood transfusion apparatus are a k...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): B01D65/10C12Q1/04
CPCB01D65/10C12Q1/04
Inventor 徐玉茵周静张丹丹魏聪田林奇韩颖周小婷柳小军孟星刘康博范汉杰王海涛高文静何孜翰陈国铭周岩屈小丽
Owner 河南省医疗器械检验所
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