WaFu Brothers plays a key role in the leak testing field of the medical industry, providing high-precision detection equipment. Its technology is applied to medical device sealing testing, ensuring the safe operation of respirators, anesthesia machines, and other equipment; used for pharmaceutical packaging sealing testing to prevent drug contamination; it also supports implantable medical devices, respiratory masks, and dialysis equipment sealing testing, ensuring patient safety. WaFu Brothers provides reliable assurance to the medical industry with advanced technology, becoming an important partner.
Laparoscopic Trocar
In 2022, a Zhejiang-based medical device company applied for EU CE certification for its disposable laparoscopic trocars. During third-party laboratory testing, the trocar valve seals were found insufficient, with CO₂ simulation tests exceeding leakage limits, resulting in certification rejection. Subsequently, the company introduced micro-leak-level leak testers (mass flow method), setting a leakage standard of ≤0.05 sccm and implementing 100% full inspection for each trocar. This successfully passed certification and elevated the product's market positioning, enabling entry into German and Italian markets.
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Electronic Blood Pressure Monitor
As a medical diagnostic device, the airtightness performance of an electronic blood pressure monitor directly affects measurement accuracy and reliability. Poor airtightness can lead to: Increased measurement error Leakage causes pressure drop, resulting in lower blood pressure readings, Reduced device lifespan Continuous air leakage forces the air pump to operate under excessive load, Safety risks Severe leakage may cause abnormal inflation of the air bladder, Non-compliance with medical standards Failure to meet medical device certifications such as YY 0670 and ISO 81060.
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Vial
In 2023, a major biopharmaceutical company in Shandong had to recall a batch of monoclonal antibody injections bound for Europe after customer laboratories detected 5‰ defective vials through helium testing. The company subsequently implemented micro-leak testers (combining pressure decay and mass flow methods) for non-destructive testing of vial closures, achieving 0.05 sccm sensitivity. This successfully passed multiple European and American regulatory audits, reducing finished product leakage risks to <0.1%.
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