An article to understand the medical industry sealing test program, medical airbag is how to efficiently complete the air tightness test

In medical device manufacturing, air tightness is the key lifeline to ensure patient safety and product efficacy, especially for the "medical device".Pneumatic circulation leggings"TheRehabilitation and Physical Therapy Airbag"For this kind of complex pneumatic products, the traditional single-channel inspection becomes the bottleneck of production due to low efficiency.

Shenzhen Jingcheng Engineering breakthrough launched the "Four-channel flow-type hermetic sealing machine", upgrading manual inspection to an automated, digitized and traceable intelligent process, cracking the contradiction between efficiency and safety with innovative technology, and injecting unprecedented precision and speed into medical manufacturing.

Ⅰ. Why is it so difficult to test medical airbag seals?

Three dimensions of the technological challenge

The challenge of recognizing tiny leaks

Leakage from medical airbags often occurs in the thermocline, joints, or micropores of the material, and can occur at a rate of less than 1 ml/min. Manual inspection relies on feeling and hearing, and leaks at this level are virtually undetectable.

Conflict between inspection time and production schedule

Accurate detection of small leaks requires a holding time long enough for pressure changes to show up. But every additional minute of detection time means a minute of waiting on the production line.

Regulatory requirements for data traceability

Medical device quality systems such as ISO13485 and EU MDR clearly require complete traceability of quality data. Manual testing records are neither complete nor reliable.

II. Technical solutions: why choose the flow type over the differential pressure type?

Medical airbag products have a special characteristic: they are often made of flexible materials that deform during the pressurization process. This deformation causes the volume of the chamber to change, which in turn affects the pressure reading.

Limitations of Differential Pressure Type Detection::

Filling → Pressure stabilization → Monitor pressure drop
        ↓
   Volume change due to material deformation
        ↓
   Pressure readings disturbed by deformation

Advantages of flow-type detection::

Inflation → constant air supply to maintain constant pressure → monitoring of supplementary flow rate
                    ↓
              Unaffected by deformation
                    ↓
           Direct measurement of leak rate

The flow-based method measures leakage rates directly, independent of material properties, and is more suitable for flexible products.

Ⅲ. Jingcheng Gongke four-channelAir tightness testing equipmentCore highlights of the

1. 4-channel parallel detection, 4 times more efficient

The equipment is equipped with four independent workstations, which can test several products at the same time.

Pneumatic circulation leg set four-channel intelligentAir tightness testing equipment

Each channel is equipped with:

• Independent gas regulator system
• Independent flow sensor
• Independent pressure control circuit

Key Technology Points: Physical isolation between channels to avoid air pressure crosstalk. Each channel's air source, sensor, and control logic are completely independent, so even if one channel is abnormal, it will not affect the testing accuracy of other channels.

For medical device manufacturers that require mass production, this means thatNearly four times the production beatThe inspection and assembly is almost seamless.

2. Intelligent verification + accurate judgment, double guarantee of security

Medical airbag products often have multiple air chambers and require simultaneous testing of multiple lines.The equipment can automatically recognize the connection order of the eight pipelines, preventing human connection errorsThe
In the airtightness test phase, the system analyzes the pressure and flow curves in real time by means of high-precision sensors, and accurately determines whether there is any leakage.
The testing logic is transparent and quantifiable, so that every 'pass' can be justified.

3. Visualized operation and code tracing

high definition computer screenReal-time display of test time, pressure change and leak rateThe code can be scanned to match the product model and batch, realizing theSeamless integration with MES systemsThe

📊 Measured data: Channel ③ takes 336.3 seconds to inspect, Channel ④ takes 296.6 seconds, and it takes about 5 minutes to inspect a single piece, which fully takes into account the depth of inspection and the production rhythm.

4. Intelligent alarms and rapid screening

The system automatically distinguishes between "OK" and "NG" status.If the test fails, the screen instantly highlights the anomaly channel, helping the QC to quickly locate and deal with the problem.

5. Industrial quality, flexible customization

As a source manufacturer, thePrecision Engineering can customize the test pressure range, test mode and judgment threshold according to the structure of customer products., ensuring that every aspect of the process is tailored to the needs of the real process.

Ⅳ. Three major benefits of data-enabled QC

norm	Enhancement	practical effect
detection channel	1 → 4	Nearly 4 times more efficient
Inspection cycle	Approx. 300 seconds	Matching medium to high tempo production lines
Judgment accuracy	±0.01ml/min	Meeting medical standards
Data traceability	Full process cloud archive	Complies with CE/FDA audit requirements

By closing the loop with data, organizations can easily respond toISO13485, EU MDR and CE certification systemsThe audit needs of the medical devices to provide a solid quality support for the export of medical devices.

V. Multi-dimensional view of the professional strength of Precision Engineering

1. Deep cultivation of technology: more than ten years of precipitation + independent core technology

Focusing on the field of airtightness testing for more than 10 years, Precision Engineering has been deeply engaged in the three core tracks of medical, automotive and new energy, and has accumulated mature experience in adapting to multiple scenarios.. Independent research and development of high-precision flow detection algorithms and pneumatic control systems, the formation of difficult to copy the technical barriers, for the detection of precision and efficiency to build a solid foundation.

2. Compliance certification: benchmarking against international standards + authoritative endorsements

Our products have passed the UDEM CE EMC/LVD directive certification (Certificate No. M.2025.206.C126129), which fully meets the EU export compliance requirements. The testing program strictly follows the EN IEC 61000, EN 61010 and EN 61326 series of international standards.With standardized processes and professional services, we have gained long-term recognition from many head medical device companies.The

3. Product Hard Power: Stable and Reliable + Full Process Traceability

Equipment equipped with automatic archiving and cloud data backup double protection function, to achieve the whole process of testing traceable and reviewableThe core components are industrial-grade components, which have been verified under long-term working conditions. The core components are selected industrial-grade components, which have been verified under long-term working conditions to ensure the stability of the detection process and guarantee the real accuracy of the data output, eliminating the hidden danger of errors.

4. Industry Value: Empowering Customers + Promoting Industry Upgrade

Customized testing solutions have been provided to a large number of medical industry manufacturers, helping customers to achieve both production consistency and testing accuracy.. With data-based and scientific testing technology, it breaks the traditional empirical testing mode and provides core support for the standardized development of the industry.

Summarize

In the quest for high-quality medical manufacturingFour-channel flow type of Jingcheng Industrial TechnologyAir tightness testing equipmentAllows companies to not only test products, but also manage data, ensure security, and earn trust.

Free Consultation: For product-specific testing program design, it is recommended to verify the technical feasibility of the actual sample test, Precision Engineering can provide free program consulting.
Field of application: Medical Rehabilitation Equipment, Pneumatic Leg Sleeves, Waterproof Electronics, Pneumatic Components, Medical Consumables QC, etc.

Original Statement:this paper was written byShenzhen Jingchenggongke Technology Co., Ltd.Written by the technical team, reproduced with attribution.Data sources:Precision Engineering internal test data and customer cases.