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Chinese National Standard Infusion Device Liquid Filtration Requirements Urgently Needed To Improve
May 25, 2018

The domestic infusion standard has very low requirements for liquid filtration.

The safety of infusion patients is very unfavorable and it is necessary to improve the infusion filtration requirements. The following are the current standards.

"One-time use of burette-type infusion set for gravity infusion" (YY 0286.2 - 2006),

It was mentioned that the pore size of the liquid filter is generally 15 μm (Figure 1 burette infusion set example).

The same is true for the other standard "Gravity infusion for single-use infusion sets" (GB 8368-2005).

    Even the “GB18458.1-2001 Special Infusion Set Part 1 Disposable Precision Filtration Infusion Set”

The filter aperture is also only required to be ≤ 5 μm.

     It is understood that particulate contamination during infusion is more common in hospitals.

So many large hospitals use liquid filters when they infuse fluids. The diameter of adult capillaries is 6~8μm.

The capillary diameter of infants and young children is 3~4μm. In addition, Japan's liquid filter standards are at three levels: 0.20, 0.45, and 0.80 μm. The three standards mentioned above are related to infusions. I recommend raising the liquid filter requirements on the infusion set to filter smaller particles. If the aperture requirements are improved, it can be divided into different grades, including 1μm, 0.45μm, and 0.20μm. The current filtration membrane can reach such a level, and it can also be done for infusion appliance companies. The increase in the pore size requirement of the infusion set's liquid filter can provide more safety to the infusion patient.

    Therefore, it is hoped that the Polymer Products Branch of the medical device industry can start the revision and upgrade of the infusion filter standard as soon as possible.

The current 15 μm and 5 μm apertures are relatively low requirements, which poses a great deal of danger to infusion patients.