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China Chaosheng Group · Zhejiang Kunying Flexible Soft Board Factory
Introduction to Rigid Flex FPC (Rigid Flex) products specifically designed for medical equipment
1、 Overview of Enterprise Entities
China Chaosheng Group has been deeply involved in high-end electronic circuit manufacturing processes such as PCB, FPC, HDI soft and hard combination board, aluminum substrate, and optical module carrier board for many years. * * Zhejiang Kunying Flexible Soft Board Factory * * is the group's specialized flexible circuit board production base, focusing on customized research and development and batch intelligent manufacturing of medical grade high reliability soft and hard combination FPC * *. It has established a full process quality control system that meets the strict requirements of the medical industry, and its products are benchmarked against IPC-6013 Class 3, the highest reliability level, ISO 13485 medical device quality management specifications, and IEC 60601 medical electrical safety standards. It can meet the compliance and inspection requirements of Class II and III medical devices, and provide stable supply chain support for the import substitution of core circuits in domestic medical equipment.
2、 Product Definition and Core Structure
Medical soft and hard combination FPC (Rigid Flex PCB), integrated with * * rigid FR-4 hard board area * * and * * flexible PI soft board area * *:
1. Rigid zone * *: High Tg temperature resistant FR-4 substrate is selected for welding and fixing surface mount components, chips, connectors, and power modules, with stable structure and resistance to vibration and impact;
2. * * Flexible Zone * *: Using * * medical grade adhesive free PI copper-clad laminate (FCCL) * *, which can be repeatedly bent, twisted, and three-dimensional shaped to fit, as a signal interconnection carrier for equipment activity end, probe insertion end, and joint rotation end;
3. * * Transition Layer * *: Exclusive rigid flex combined with transition stress relief technology, laminated without bubbles or delamination, with a peel strength of ≥ 0.8N/mm, eliminating the risk of long-term bending, delamination, and fracture. Integrated molding eliminates external wiring and connectors, greatly reducing solder joint failure points.
3、 Medical grade core technical parameters (Kunying factory production standards)
（1） Process capability
1. Layers: High end medical grade soft and hard composite boards with 2-12 layers can be mass-produced, supporting any order of HDI blind buried hole structure;
2. Fine circuit: minimum line width/line spacing of 3mil/3mil (0.075mm), minimum laser blind hole of 0.1mm, interlayer alignment accuracy of ± 0.03mm;
3. Thickness control: The thinnest part in the flexible zone is 0.05mm, and the overall thickness of the finished product can be customized according to needs. The bending radius can be as low as 5 times the thickness of the board;
4. Surface treatment: Medical grade immersion gold (ENIG), immersion palladium OSP， Antioxidant and resistant to multiple high-temperature and high-pressure sterilization;
5. Copper thickness: flexible area 1/2OZ-1OZ, high current rigid area up to 2OZ, suitable for pulse stimulation and high-power driving circuits.
（2） Medical reliability hard index (core competitiveness)
1. * * Biosafety Compliance**
The substrate, cover film, and adhesive have all passed the ISO 10993 biocompatibility test, with cytotoxicity level 0, no skin irritation, and no sensitization reaction; Implant grade products can be packaged with Parylene vacuum coating, which is resistant to long-term corrosion by human body fluids and has an insulation resistance of ≥ 10 ¹² Ω.
2. Bending fatigue life**
Dynamic bending ≥ 100000 times without copper foil breakage, high-end implant models can achieve a cycle life of up to 200000 times, suitable for repeated intubation of endoscopes, daily bending of wearable devices, and high-frequency activity scenarios of surgical instruments and joints.
3. Environmental stability resistance**
The working temperature range is -40 ℃~125 ℃, and it can withstand high temperature and high pressure steam sterilization at 134 ℃, ethylene oxide disinfection, and repeated wiping with alcohol/disinfectant; Resistant to sweat, body fluids, and medical chemical agents.
4. Signal integrity assurance**
Built in differential impedance control, full layer electromagnetic shielding structure, low dielectric loss, suppression of weak bioelectric signal (ECG, EMG, nerve pulse) transmission interference, zero distortion of imaging equipment and multi-channel probe signals.
4、 Downstream medical equipment full scenario application 1
Minimally invasive/endoscopic diagnostic and therapeutic equipment (main product category)
-Electronic endoscopes (gastrointestinal endoscopy, laryngoscopy, biliary endoscopy) with ultra-fine probe soft hard combination plate, flexible segment passing through 3-5mm small pipeline, rigid end carrying image sensor and driver chip;
-Ultrasonic probe array board, surgical ablation electrode board, minimally invasive surgical robot actuator flexible interconnection board.
2. Implantable Class III high-end medical devices
Pacemakers, implantable defibrillators, deep brain stimulators (DBS), cochlear implants, and retinal implants with micro soft hard combination plates, ultra-thin and miniaturized design, long-term stable operation in the body, and low foreign body irritation.
3. Wearable&Dynamic Health Monitoring Devices
-Dynamic electrocardiogram Holter, patch type blood glucose CGM monitor, flexible electrode circuit board for blood oxygen pulse monitoring;
-Intelligent insulin pump, rehabilitation exoskeleton robot joint sensing circuit board, flexible module for electromyographic signal acquisition.
4. In vitro diagnostic POCT and laboratory equipment
Blood gas analyzer, portable immune detector, core circuit board of fluorescence quantitative detection card, internal interconnection rigid flex binding board of medical monitor.
5、 Compared to ordinary FPC/split cable, the core advantages
1. * * Reliability index level improvement**
Integrated molding replaces the separate solution of "hard board+FPC+connector", reducing the number of solder joints by more than 60%, avoiding the risk of poor contact and open circuit caused by vibration and bending, and meeting the safety requirements of "zero fault tolerance" for medical equipment;
2. Ultimate miniaturization and weight reduction**
Three dimensional layout, able to fit the irregular space inside the device cavity, reducing the overall volume by 30% -50% and weight by 40%, perfectly adapting to the strict space limitations of handheld portable and implantable devices;
3. * * Long term comprehensive cost optimization**
The one-time process completes structural integration, simplifies downstream assembly processes, significantly reduces repair rates, and has a much lower full lifecycle failure rate than traditional wire harness splicing solutions;
4. Highly customizable degree of freedom**
According to the internal structure of the device, any irregular window opening, reinforcement design, customized shielding layer, and precise impedance matching can be made, supporting small batch samples and stable delivery in large quantities.
6、 Factory Capacity and Delivery Guarantee (Kunying Factory Area, Zhejiang)
1. Clean Room: Independently produced by a medical dedicated line with a cleanliness level of 10000, to avoid micro short circuit hazards caused by dust and impurities;
2. Full link testing: AOI automatic optical testing, impedance testing, bending fatigue testing, high and low temperature cycling aging, high-voltage insulation withstand voltage testing, salt spray corrosion resistance testing, all verification items, and medical grade testing reports issued for each batch;
3. Delivery mode: Support R&D sampling (3-7 days for delivery), small batch trial production, long-term supply for large orders, and one-stop service for PCBA mounting;
4. Compliance documents: Material certification can be provided RoHS、REACH、 Biocompatibility testing report, system certification certificate, to assist customers in injecting medical devices
7、 Conclusion of Promotion
China Chaosheng Group Zhejiang Kunying Flexible Soft Board Factory creates every soft and hard integrated FPC with strict medical grade manufacturing standards, safeguarding the operation safety of medical equipment with precision circuit reliability, and assisting in the localization and replacement of core electronic components of high-end medical devices in China. It can accept one-on-one customized development of drawings and specifications.
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