The special requirements for PCB (printed circuit board) assembly of medical equipment are mainly reflected in the following aspects:
First, high reliability and stability
Long-term stable operation: Medical equipment needs to run stably for a long time, so the PCB and its assembled components must have ultra-high reliability to avoid any failure or failure.
Redundancy design: For critical signal paths and power supply lines, redundancy design is usually adopted and backup is set to ensure that when the main module fails, the backup can be immediately put into use to ensure the normal operation of the device.
Strict testing: After the PCB assembly is completed, strict testing, such as ICT (online testing), FCT (functional testing) and aging testing, is required to ensure that each component can work normally and the overall performance of the equipment is stable and reliable.
Second, comply with regulations and standards
Medical industry standards: Medical device PCB assembly must meet relevant medical industry standards, such as ISO 13485 medical device quality management system certification, to ensure compliance with the quality management system.
Electromagnetic Compatibility (EMC) standards: Medical equipment should not interfere with other equipment while working, but also be resistant to external electromagnetic interference. Therefore, PCB assembly must comply with relevant EMC standards, such as YY 9706.102, etc.
Electrical safety standards: Medical equipment is located in an environment full of various sources of electrical interference, while ensuring absolute safety for patients and operators. Therefore, PCB assembly must comply with electrical safety standards, such as GB9796.1/IEC 60601-1, etc.
Third, material selection and quality control
Comply with medical industry standards: PCB and its assembled components must use materials that meet medical industry standards, such as high temperature resistance, corrosion resistance, non-toxicity, etc.
Strict control of the source and quality of materials: Strict control of the source and quality of materials to ensure that all materials meet the relevant standards and specifications to ensure the safety and reliability of the final product.
Use of environmentally friendly materials: With the improvement of environmental awareness, PCB assembly of medical equipment is also paying more and more attention to the use of environmentally friendly materials, such as lead-free solder, to reduce pollution to the environment.
Fourth, fine layout and wiring
High density layout: Medical devices often need to complete complex functions in a limited space, so PCBS need to have high density wiring and miniaturization design.
Fine wiring: In order to achieve high-density electronic component integration, medical PCB needs fine wiring, reduce signal interference, and improve the stability and reliability of the circuit.
Reasonable hierarchical structure: The use of reasonable hierarchical structure and wiring design, the different functional modules are distributed in different levels to improve anti-interference ability.
Fifth, special design requirements
Isolation and protective design: Specific medical devices may require isolation and protective measures in design to protect patient and treatment safety.
Biocompatibility and chemical safety: The PCB of some medical devices may be in indirect or direct contact with human tissues and body fluids, so its materials must be biocompatible and cannot release harmful substances, causing human allergies, inflammation or other adverse reactions.
Miniaturization design: With the portability and miniaturization of medical devices, PCB design also needs to be miniaturized to accommodate the compact equipment space.
Sixth, strict quality control
Process control: In the PCB assembly process, the key processes are strictly controlled, such as solder paste printing, component mounting, reflow welding, etc., to ensure that each process meets the process requirements.
Detection and testing: The use of advanced detection technology and equipment, such as AOI (automatic optical inspection), X-ray inspection, etc., for real-time monitoring and detection of PCB assembly quality, timely detection and correction of problems.
Document and record management: In the PCB assembly process, be sure to keep detailed documents and records, including design documents, component lists, process flows, test reports, etc., for follow-up traceability and quality control.
