Infusion set is a common three types of medical devices, mainly used for intravenous infusion in hospitals. Every kind of device that directly contacts the human body is important from the safety evaluation before production to the production to the supervision sampling after the market. Because of the diversity of medical devices, many do not have a perfect unified standard. More provided is a norm similar to the guiding principles. Specifically, for example, the bacterial endotoxin test of an infusion set, apply appropriate tests to evaluate the infusion set or air inlet device for pyrogen-free. The results should indicate that the infusion set is non-pyrogenic. The limit value is specified in the product standard and should be as low as possible. It is recommended that the limit of bacterial endotoxins for infusion, blood transfusion, and syringes does not exceed 20EU per piece, and that each piece of medical equipment in contact with cerebrospinal fluid and intrathoracic applications does not exceed 2.15EU.
The bacterial endotoxin test water was injected into the infusion set and cultured at 37°C for 1h to obtain a sample extract. The bacterial endotoxin test method was used to check the sample extract and observe the gel formation to determine whether the sample pyrogen meets the requirements.
Disposable infusion set is the channel through which the medicinal solution enters the human body, and the endotoxin on the infusion set may be brought into the body by the liquid. The inspection dose of the sample extract was determined according to the inspection dose of the large infusion (10% glucose injection), M=10mL·kg-1, and the threshold dose of endotoxin K=5EU.kg-1 during intravenous administration.
First, dissolve a bacterial endotoxin working standard with bacterial endotoxin test water, and then take out a part and dilute it with test water. The remaining part is diluted with the sample extract solution to the above concentration to a series of concentrations. Incubate in a water bath at (37±1)℃ for 1 h. Make 4 tubes in parallel for each concentration. Finally, the geometric mean value Es of the end-point concentration of the endotoxin solution made from the bacterial endotoxin test water and the geometric mean value Et of the end-point concentration of the endotoxin solution made from the sample extraction solution were calculated. The results can indicate whether the sample extracts interfere with the tritium test.
|Project name||Endotoxin testing in infusion set|
|Testing purpose||Infusion set will directly contact human tissues and organs, therefore， endotoxins must be tested before use.|
|Testing cycle||3-5 days.|
|Service including||We provide you with raw data and test reports.|
Creative BioMart offers a corresponding endotoxin detection service. You can purchase the corresponding endotoxin removal kit and related accessory products according to the needs of your own samples. We guarantee that all instruments, water, reagents, and consumables used in the experiment are free of endotoxins, and the experiment is conducted in a clean room to ensure that low levels of endotoxins are returned to the sample. In addition, we can also provide you with related services including:
If you are interested in our services, please contact us for more details.