Description

Medical PCBA (Printed Circuit Board Assembly) is a printed circuit board assembly specifically used in the medical field. ISO 13485 certified medical PCBA (Printed Circuit Board Assembly) is specially designed for the medical equipment and health electronics fields. Through surface mount technology (SMT) and through-hole insertion processes, chips, resistors, capacitors, and inductors are integrated on medical-grade PCB substrates to form core electronic modules with specific functions.

1.Core Advantages

1.Medical-grade high-precision manufacturing

• Adopting micron-level mounting process to ensure the signal transmission accuracy of diagnostic equipment (such as MRI/ultrasound systems) reaches ±0.01%, and meeting the sub-millisecond-level timing control requirements of life support equipment (such as pacemakers).

2.Reliability guarantee throughout the life cycle

• Passed the 85℃/85% RH temperature and humidity cycle test and the wide temperature range verification from -40℃ to +125℃. Selected medical-grade lead-free solder (SnAg3.0Cu0.5) and military-grade FR4 substrate to ensure more than 10 years of MTBF (mean time between failures).

3.Customized biocompatible design

• Biocompatible coating treatment for flexible PCBs and implantable devices of wearable devices, compliant with USP Class VI plastic standards. Encapsulated with medical-grade epoxy resin to meet the long-term compatibility requirements with human tissues.

4.Full-process compliance system

• Follow ISO 13485:2016 medical device quality management system, obtain FDA 21 CFR Part 820 and EU certifications, establish a traceability system from raw material tracing (such as medical-grade resistance-capacitance components) to finished products, and provide complete biocompatibility test reports and sterilization verification documents.

[Application Areas]

• Diagnostic equipment: Medical imaging equipment PCBA, in vitro detection analyzer module.
• Therapeutic equipment: Laser therapy instrument control board, hemodialysis instrument drive circuit.
• Monitoring equipment: Multi-parameter monitor motherboard, wearable health monitoring system.
• Implantable device: Nerve stimulator circuit, cochlear implant signal processing module.

2.Manufacturing Process(ISO 13485 certification system)

（1）Medical-grade substrate preparation

• Adopt FR4/G10 base material conforming to IPC-2223 standard and support polyimide flexible substrate for implantable devices
• Implement biocompatible surface treatment (such as OSP, electroless nickel and gold), and comply with USP Class VI plastic standard

• Solder paste printing: DEK Horizon 03iX equipment achieves ±5μm accuracy and supports 01005 component placement
• SMT placement: Panasonic NPM-W2 high-speed placement machine with an accuracy of ±25μm/4σ
• Reflow soldering: BTU Pyramax 1500 nitrogen-protected furnace ensures lead-free welding (SnAg3.0Cu0.5) with TAL≥95%.

• Implantable devices: Adopt laser sealed welding and epoxy molding compound (EMC) packaging
• Wearable devices: Implement IP67 waterproof coating process and pass salt spray test (ASTM B117)

• Online detection: Omron AOI equipment + X-ray detection (GE InSpector 4000)
• Reliability verification: Temperature and humidity cycling (85℃/85% RH, 1000h), vibration test (random vibration 20G, 20-2000Hz)
• Sterilization treatment: Support EO sterilization (ISO 11135) and irradiation sterilization (ISO 11137)

3.Medical electronics application matrix

• CT/X-ray Equipment: 16-slice CT control board, supporting DICOM 3.0 protocol data processing
• Ultrasound Diagnostic Instrument: Phased Array probe drive module, realizing 20MHz signal acquisition
• MRI Equipment: Gradient power amplifier board, meeting the gradient field switching requirement of 100μs rising edge

• Automatic biochemical analyzer: 384-well plate detection module, supporting optical signal processing of microplate reader
• Blood gas analyzer: Microfluidic chip control circuit, realizing synchronous detection of multiple parameters such as pH/CO₂/O₂

• Holmium laser lithotripter: Q-switch laser drive board, adjustable pulse width of 50-100μs
• High-frequency electrosurgical unit: Power output control module, supporting switching between continuous/pulse modes of 200W

Life support equipment:

• Ventilator: Proportional valve control circuit, response time < 10ms
• Hemodialysis machine: Blood leakage detection module, with an accuracy of up to 0.35 ml/min

• Cardiac pacemaker: ASIC control circuit, supports DDD/R dual-chamber pacing mode
• Left ventricular assist device: Brushless motor drive board, speed control accuracy ±0.1%

• Deep brain stimulator: Constant current output module, current accuracy ±5μA
• Artificial cochlea: 24-channel signal processing board, supports CIQ 2.0 standard

• Dynamic electrocardiogram: 12-lead signal acquisition module, supports real-time analysis of ECG waveforms
• Smart blood glucose meter: Electrochemical sensor interface board, detection accuracy ±10%