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PCBA Application and Assembly Standards in Medical Grade Equipment

2024-05-28

Circuit boards are one of the most important components in electronics. It is the support body of electronic components and carries the connections between electronic components. At the same time, circuit board applications have become an indispensable component in the medical electronic equipment industry to implement various medical electronic terminal equipment. Printed circuit board assembly realizes the circuit connection between medical equipment electronic components and enables various electronic components to be installed firmly. Therefore, medical and PCB assembly manufacturing has a close and indispensable relationship. Medical device manufacturing is inseparable from PCB design and fabrication technology, and the high-quality standards adhered to by the medical market also promote the development of PCB manufacturing industry technology to high levels and high requirements.

1. PCB Assembly Is Widely Used In The Medical Field

● Wearable Medical Equipment  

Wearable medical equipment is mainly used to identify the body's physical characteristics and status, monitor the user's physical condition, exercise status, and metabolic status at all times, and digitally present the life posture. With the development of artificial intelligence and big data technology, wearable medical devices can sense, record, analyze, regulate, intervene and even treat diseases or maintain health with software support, overcoming traditional medical devices' shortcomings. Therefore, wearable medical devices often require devices to become smaller and smaller, focusing on lightness and ease of wear without affecting data accuracy.

Behind this, the continuous innovation of circuit board assembly technology is indispensable. By optimizing the circuit layout, using micro-components and advanced welding processes, wearable medical devices PCB board can be highly integrated and miniaturized, providing patients with more convenient testing methods.

● Implantable Medical Devices

Implantable medical devices, as special products related to people's lives and health, usually require high reliability, miniaturization and biocompatibility. Different implants will achieve goals for different medical conditions, and the characteristics of implants' Unstable properties also affect PCB design and PCBA manufacturing. Implantable medical devices need to be very small in design to be successfully implanted into the human body. As one of the core parts, PCB assembly has a high degree of reliability. The use of high-quality materials and advanced manufacturing technology improves the performance stability and service life of the entire equipment. Implantable medical device PCB technology can support the application of high-density interconnection (HDI), multi-layer design, and flexible PCB, allowing more functions to be integrated on compact circuit boards.

For example: 
(1) deaf-mute people can hear sounds through implanted hearing devices (such as cochlear implants) by manufacturing sophisticated PCB assembly to process signals and convert sounds.
(2) Circuit board assembly uses high-density assembly, micro-components and multi-layer board technology to manufacture neurostimulators. Circuit board manages the generation and transmission of electrical signals, which can benefit patients with chronic pain and Parkinson's disease.

● Heart Rate Health Type Medical Devices

Heart rate health-type medical devices are inseparable from circuit board assembly. Circuit board undertakes key tasks such as signal transmission, data processing, power management, monitoring, recording and regulating the cardiac activity of medical equipment.

For example: 

(1) Heart rate monitors are usually worn on the wrist. Through high-precision and high-sensitivity PCB design, the sensor on the PCB board collects heart rate data, amplifies, filters and digitizes the collected signals, and transmits the data to the computer via Bluetooth on your smartphone or other device. 

(2) Electrocardiogram (ECG/EKG) equipment, the multi-channel acquisition circuit integrated on the PCB is used to obtain detailed ECG signals, and processed through signal processing, the communication module on the PCB (such as Bluetooth, Wi-Fi or other wireless communication technologies) The resulting signal is transmitted to an external device or the cloud for further analysis and recording, and an electrocardiogram is generated for diagnosis.

● Medical Sterilization-type Equipment

Bacterial infection control touches everyone's heartstrings. Whether it is the environment where people live, schools, subway stations, offices and other public places, they are all places where people come into contact with each other. Disinfection and sterilization of the environment in these places is important measures. The need for medical sterilization equipment is even more urgent for hospital safety, medical workers, and patients. PCBA manufacturing plays a core role in medical sterilization equipment. From control and drive circuits, power management, sensor interfaces, user interfaces and communications, to safety monitoring and data recording, every link is inseparable from the PCB fabrication support. Efficient, reliable and intelligent PCBA design and manufacturing are key to ensuring the proper functionality and safe operation.

For example

(1)Ultraviolet sterilizer: logic circuit is integrated on the PCB to control the start and stop of the sterilization process of the ultraviolet lamp, adjust the working parameters (such as ultraviolet intensity, ozone concentration) and timing functions, and monitor the working time to ensure the sterilization effect.

(2)Advanced sterilization and disinfection robot: The power management module on the PCB is responsible for converting external power to the required voltage and current, and ensuring that the disinfection robot operates stably under various working conditions, optimizing battery usage efficiency and extending the working time of the equipment. 

The disinfection robot can perform multiple disinfections within 24 hours, purify the air, and comprehensively improve work efficiency. It can also strengthen protective measures in public places in hospitals. At the same time, the circuit board of the disinfection robot is integrated with components for display and user interaction, such as LED indicators, LCD screens and buttons. By setting the parameters of the device usage interface, starting and stopping the device and viewing the working status. In addition, the memory chip on the PCB is used to record the operating data of the disinfection robot, such as working hours, number of sterilizations, and sensor readings. This provides a historical record for reference by users or maintainers.

PCB assembly is widely used in the medical field

2. Medical Grade PCBA Assembly Standards

The medical PCBA manufacturing and medical devices is strict and special. Medical equipment needs to follow strict product certification standards and meet the highest quality and safety standards, whether in PCB design, SMT processing, PCB assembly, testing or final inspection to ensure the safety and reliability of the equipment.

● ISO 13485

ISO 13485 is a quality management system standard designed specifically for the medical device industry. This standard requires PCBA manufacturers to have an effective quality management system in the design, development, production, installation and service of medical devices. It covers aspects such as risk management, document control, process validation and regulatory compliance.

● ISO 14971

ISO 14971 is an international standard for medical device risk management, requiring systematic risk management throughout the entire life cycle of medical devices, including risk assessment, risk control and residual risk assessment.

●IEC 60601

IEC 60601 is the basic safety and basic performance standard for medical electrical equipment, including various requirements for electrical safety, mechanical safety, software verification and environmental testing of medical equipment. The safety requirements for electrical and electronic components are specified in detail in Part 60601-1.

● IPC-A-610

IPC-A-610 is the acceptability standard for electronic component assembly and requires PCBA assembly quality requirements, including solder joint quality, component placement, cleanliness, and defect determination.

● IPC-A-600

IPC-A-600 guides the inspection and acceptability of PCBs to ensure that PCBs meet expected performance and safety requirements during manufacturing and use. PCBs in medical devices are typically required to meet Class 3 standards, which is the highest quality and reliability level in IPC-A-600.

● RoHS and REACH

RoHS (Restriction of Hazardous Substances) and REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) are regulations for hazardous substances, ensuring that PCBA components do not contain hazardous substances exceeding specified limits, such as lead, mercury, cadmium, hexavalent chromium, etc. To comply with environmental protection and user safety requirements.

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