Expert Group from Medical Polymer Products Subcommittee of China Medical Device Association Visits Xinna Medical to Discuss Infusion Set Standard Revision, Jointly Promoting High-Quality Industry Deve

"Repost from the Secretariat of Yuhuan Medical Device and Packaging Industry Association"

Experts Conduct Specialized Seminar on Air Filter membrane Standards for GB8368 Revision
May 21 2025— A delegation led by Zhang Honghui, Chief Advisor of the Medical Polymer Products Branch of the China Medical Device Industry Association, along with technical experts, visited Zhejiang Xinna Medical Devices Technology Co., Ltd. to conduct a focused seminar on the technical requirements for air filter membranes (vent membranes) under the ongoing revision of China’s mandatory national standard GB8368: Disposable Infusion Sets for Gravity Infusion. The discussions, suPPorted by the association’s secretariat, centered on critical topics including material selection for vent membranes, optimization of key physical properties (airflow capacity and hydrophobicity), and compatibility testing for bacterial filtration efficacy.

The expert panel emphasized that the upgraded GB8368 standard will prioritize enhancing performance specifications for vent membrane materials. Scientific validation is required to confirm the clinical suitability of materials such as polyester, while refining the evaluation framework for balancing airflow efficiency and hydrophobic characteristics. Regarding bacterial filtration—a key clinical concern—the panel proposed adopting advanced international testing methodologies to develop practical validation protocols tailored to domestic production realities. During the meeting, national association experts announced plans to collaborate with Xinna Medical on establishing a group standard for next-generation vent membrane materials, leveraging systematic data collection to support the technical advancement of mandatory standard revisions.

The representative of Zhejiang Xinna Medical stated that the company has established a dedicated task force to address standard development requirements, aiming to complete multi-batch performance validation of new materials and clinical feedback collection within the year. This collaboration will empower the company to achieve dual breakthroughs in technological advancement and standard leadership, driving domestically produced infusion sets to fully align with international benchmarks in safety, efficacy, and cost-effectiveness—ultimately benefiting end-user patients.

Industry analysts noted that this in-depth collaboration between academia, research, and industry signals a strategic shift in China’s medical device standardization efforts—from a "follow-the-leader" model to one driven by innovation. This initiative is expected to inject new momentum into high-quality sector development.

On the same day, the association issued an Explanation on Air Filter Materials for Infusion Sets to Zhejiang Xinna Medical, supporting its application for an environmental exemption for polyfluorinated lipid materials used in invasive or implantable medical devices.