PCBA boards are an important part of today’s electronics industry, enabling machines to improve and advance. While printed circuit boards are used in many electronic devices, including LEDs, water dispensers, and air conditioners, their use in the medical device is one of the most cutting-edge applications.
医療用PCB は、特定の プリント基板の種類 医療産業で使用されています。中国の医療産業が伝統的な中国医学から西洋医学へと移行するにつれ、医療用電子機器の需要が飛躍的に高まっています。そのため、中国の医療用PCB製造・組立技術の発展が促され、FSテクノロジーは信頼できる企業となっています。 医療機器用PCBAメーカー. The medical circuit produced by FS Technology is widely used in a range of medical devices, including ultrasound machines, patient monitoring equipment, medical imaging systems, and other devices that require precise and reliable electronic control. These PCBA play a crucial role in controlling and regulating the electronic functions of medical equipment.
Get a Medical PCB Assembly Quote from FS Technology
If you’re looking for a top-tier manufacturer of medical PCB/PCBA, go no further than FS Technology. Since medical electronics are related to human health, they must meet strict safety and reliability standards. For example, most manufacturers can provide basic certifications such as ISO9001 と ISO14001. However, it is far from enough for a company like FS Technology that has the ability to provide PCBA services for the medical industry. We must meet medical industry standards such as ISO13485認証取得.また、埋め込み型医療用電子機器の中には、より高い精度と安定性が求められるものがあり、過酷な医療環境に耐える設計が必要であること、製造時に多くの試験が必要であること、組み立て品質時に部品のはんだ付け性を確保する必要があることなどが挙げられます。
What medical electronic PCB have been produced?
の勃発以来 COVID-19 pandemic, the global demand for medical electronics has remained high. In this environment, FS Technology has received many inquiries from the medical industry. Currently, the majority of the medical PCBA we produce are for electronic forehead thermometers. However, we also manufacture PCBA for other medical devices such as CT scanners, surgical lights, and a range of other products. The following are some examples of the PCBA for medical products that we can provide to our customers:
Medical PCB Manufacturing : From Design to Assembly
Medical PCB will be directly used to build medical products to ensure the health of patients, which requires manufacturers to implement the most stringent standards from design to manufacturing to assembly to fulfill such orders. The following is the production process of FS Technology:
Step 1: Build Schematic
Schematic is a visual representation of the electronic components and connections that constitute a printed circuit board. The schematic offers a clear overview of the circuit, enabling engineers to identify potential issues and make necessary adjustments before proceeding to the production phases. In a schematic diagram, components are represented by symbols, and connections between them are depicted by lines. These symbols are standardized, making it easy for 回路基板の部品識別. For instance, a resistor is typically represented by a zigzag line, while two parallel lines denote a capacitor.
Usually, the customer carries out this process. If you do not have the ability in this area, FS Technology’s engineering team will assist you in completing this process! In order to complete the process, you must provide all the essential information about the project to FS Technology to produce basic drawings. Some crucial details include the intended use of PCB, the type of circuit board, the required power, and the material used. All of these details must be accurate, and the initial medical device PCB design should be based on them.
Step 2: Layout Design
The next stage after the initial schematic design is to create the layout for the medical printed circuit board, and it is recommended to use professional PCB設計ソフトウェア for this process. In modern healthcare systems, various implantable and miniaturized devices are used, and to reduce the size of the boards, it is essential to arrange them as closely as possible to each other. Additionally, careful consideration is given to the power requirements of components, overall circuit power consumption, electromagnetic interference, and thermal management to ensure the proper functioning of the circuit. To ensure the reliable and efficient operation of medical device PCB, it is crucial to follow PCB設計ガイドライン and plan a reasonable component and bare board layout. Here are some suggestions:
- チェック リフローはんだ付け requirements twice to ensure that SMD部品 stay cool while being assembled.
Step 3: Files for Final Work
Once the design is complete, your final job is to send the ガーバー or CAD data to the China medical PCB assembly manufacturer. Once the design and manufacturing files are approved, PCB fabrication services can officially begin to turn your digital design into reality.
While there are many manufacturers worldwide to choose from, it is essential to look for ISO 13485 certification for medical PCB projects. If you are unsure about proceeding with the project, you can send the files and instructions outlined above to FS Technology. As the best among 1-10 layer medical PCB manufacturers, we can provide you with the necessary expertise and quality assurance.
At this step, the medical PCB manufacturing factory becomes involved in the process and utilizes a plotter printer to convert the design files for circuit boards into films, which serve as photo negatives of the diagram.
This step involves manufacturing the inner-layer circuits for medical PCB to establish conductive pathways on different layers. If your project requires a more complex multilayer medical PCB, this step must be repeated until all inner-layer circuits are printed and etched. Finally, they are aligned and laminated to form a complete inner layer. The specific operations are as follows:
- Laminate copper layers onto each side of the fiberglass substrate.
- Align a thin film with the copper layers and place it on top.
- Use ultraviolet (UV) light exposure to cure and protect the underlying copper.
- Employ a chemical solution to develop the circuit board, removing uncured transparent ink, leaving behind copper traces and circuits.
- Etch to remove excess copper foil, with black ink on the film ensuring that only copper in unwanted areas is etched away.
Once all necessary inner layers have undergone etching, printing, and lamination, ensuring cleanliness, different layers need to be combined to form a complete printed circuit board. This involves the drilling process to connect with the inner layers. Most manufacturers employ traditional CNC drilling, which may not suffice for medical PCB with high precision requirements.
Take, for example, medical pacemaker PCB, where even typical devices may have over a hundred drill holes, not to mention more sophisticated instruments. The time required for manufacturing is just one aspect of the challenge; what’s even more critical is that any minor deviation can lead to assembly failures.
To address this challenge, FS Technology utilizes optical drilling machines and laser drilling processes to achieve precision drilling. This involves a machine that drives pins through alignment holes to align the inner and outer layers, ensuring the effectiveness of PTH during スルーホールPCBアセンブリ.
Step 4: Outer Layer Imaging
Imaging the outer layer is a crucial step in the プリント基板製造工程.に別のフォトレジストを塗布する。 PCBメディカルパネルこれは、プリント基板の外側の銅層にプリント基板のデザインのイメージを転写するものです。ただし、イメージングでは、フォトレジストは外層にのみ塗布されます。この工程は、清潔で安全な場所で行われます。
During this process, any copper that doesn’t belong to the outer layer is removed, and an additional layer of copper is added using electroplating. Electroplated tin is used to protect critical areas of copper after the initial copper bath. Once the outer layer etching is completed, the panel can undergo AOIインスペクション checks to ensure that even medical aesthetic PCB boards with complex circuits meet the necessary specifications.
Step 6: Solder Mask and Silk Screen
After the circuitry manufacturing is complete, an はんだマスク is applied to protect the outer layer of the medical printed circuit board and to apply silk screen details such as company ID, manufacturer logos, symbols, component identifiers, pin locators, and other prominent markings or features. The process involves:
- Cleaning the medical PCB panel to remove any contaminants.
- Applying epoxy resin ink and solder mask film to the surface of the circuit board.
- Exposing to UV light to cure the areas where soldering is not required in the solder mask layer.
- Removing the areas that don’t need masking and placing the board in an oven to solidify the solder mask layer.
- Using an inkjet printer to directly print information details onto the board.
Step 7: Surface Finishing
Depending on the needs of the customer, it may be necessary to apply a 表面仕上げ to the finished medical PCB, which involves applying a coating of conductive material to the surface of the board.
ソルダーペーストのステンシル技術は、第一段階として PCB組立工程. In this step, a PCBステンシル is used to cover the circuit board so that only the portion of the board that will be mounted with a component is visible. This makes it easier to apply the solder paste solely to the board’s areas where the components will be placed.
などの植込み型医療用電子機器。 人工内耳 と 人工眼球, typically have many electronic components in their internal structure. However, smaller devices present challenges in the picking and placing process, making it more difficult to maintain precision. To achieve the high accuracy required for assembling PCB for medical cochlear implants, FS Technology uses robotic equipment. Robots are responsible for picking and mounting surface-mount components onto circuit boards, ensuring that the components are precisely placed on the solder paste with the mounting mechanism.
があります。 reflow soldering process is designed to strengthen the connections between the circuit board and electrical components. To achieve this, a conveyor belt is used to move the circuit board through a large reflow oven. The solder paste is melted by heating the PCBA board to around 2500 degrees Celsius during the process. After being heated in the oven, the medical PCBA goes through a series of coolers, which help the solder paste cool and harden, resulting in strong connections between the electrical components and the board.
については、注意が必要です。 double-layered medical PCBまた、ステンシルやリフローの工程は順番が決まっています。電気部品が少なく扱いやすい基板側を先に完成させます。
We emphasize the precision, reliability, and critical nature of medical circuit boards. Therefore, finding reliable manufacturers and excellent PCBA facilities and ensuring they have ISO 13485 certification is of utmost importance. Even when they meet these criteria, it is still necessary to inspect their PCBテストサービス.
In addition to manual inspections that run throughout the production process, including SPI and AOI, 機能試験 is performed at the final stage of assembling medical PCB. This ensures that the mainboard functions as expected and meets the high standards set by the medical industry.
After testing is completed, a thorough cleaning of the circuit board is carried out to remove any potential residues such as oil, solder flux, or other contaminants. Additionally, due to the specific requirements of the product, customers may also need specialized processes for medical PCBA production, such as sterile handling, based on the specific application type.
Price of Medical Device PCB
と比べると 民生用電子基板, the price of medical device PCB is much higher due to the complexity of the processes and stringent requirements. For general electronics, FS Technology follows IPC-A-610-G-1 as the minimum standard, which is not sufficient for the medical industry. Therefore, it requires the adoption of level 2, level 3, or even higher execution standards. The result of these higher standards is increased production complexity, but FS Technology ensures to provide customers with more competitive medical PCBA services compared to peers!
Difficulties and Overcoming
The manufacturing challenges manifest in various aspects, including miniaturization, precision, and more. With the gradual advancement of medical technology, the demand and requirements for implantable and wearable devices are increasing. These products rely on the support of high-density, flexibility, and miniature components. High-density implies the need to stack more layers, and as the number of layers increases, the manufacturing complexity and failure rate also rise. Secondly, flexibility means the use of a flexible PCB that is three-dimensional space-friendly. Compared to traditional PCB, it is harder to construct and use more expensive materials like polyimide as substrates. More importantly, there are the procurement costs of components. To ensure requirements for miniaturization, multifunctionality, and high reliability, SMD部品 are essential. The procurement costs for these components are higher, and due to their small pins, the PCBA process becomes more challenging. Furthermore, some specific devices have additional requirements, such as using thermal-sensitive components in medical defibrillator PCB, and the requirement that components used in implantable medical PCB must withstand high-pressure sterilization.
High-End Medical PCB
High-Density Interconnect is one of the core technologies for building modern medical equipment PCB, aimed at achieving more electronic components and connections within limited PCB space. A circuit board constructed using this technology is known as HDI PCB. Due to the intricate processes involved, such as fine traces, blind vias, and buried vias, HDI PCB can be expensive, but they are well worth the investment.
In remote medical applications, there is zero tolerance for signal delays or interruptions. Even a slight deviation of 0.1 seconds could be life-threatening for patients. Medical-grade HDI PCB ensure signal transmission speed and mitigate various response issues. Furthermore, by implementing certain design and engineering improvements, these high-density circuit boards can be endowed with the ability to resist electromagnetic interference and noise. This can be achieved through measures like ground plane planning, interlayer shielding, and EMI filtering.
Currently, most medical CT scanning devices and multimodal physiological and electrocardiogram (ECG) monitors benefit from the true floating-point inputs enabled by HDI PCB.
The medical industry has a significant demand for フレキシブルPCB due to their advantages such as miniaturization, design freedom, and flexibility. These characteristics meet the requirements of medical devices for lightweight, compact, and reliable solutions.
Medical electronic products must withstand harsh conditions within the human body while providing high reliability and electrical performance, making flexible circuits an ideal choice for such applications. They are typically made from thin and flexible materials like polyimide or polyester, allowing them to bend, fold, or twist to fit tight spaces or complex shapes. Furthermore, the design of flexible PCB can accommodate temperature variations, provide waterproofing, maintain sterility, and allow for multiple reassemblies.
Various medical devices rely on flexible circuits as their core components, including pacemakers, defibrillators, neurostimulators, ultrasound machines, endoscopes, and more.
In contrast, リジッドPCB can provide a more reliable internal structure compared to flexible PCB, as manufacturers can place components on a more stable platform. However, due to their inability to fold, they may not offer the advantage of miniaturization, and thus, they rely on the benefits of multi-layer structures to accommodate more components.
In many high-end medical products, rigid PCB is commonly found. These include surgical robots, X-ray machines, MRI devices, electrocardiographs, and chemotherapy pumps. Most medical equipment manufacturers opt for 多層PCB for such applications. The materials used for these PCB include glass epoxy resin, aluminum, ceramics, and more.
The development process for medical devices includes extra considerations and requirements beyond what is generally required for creating non-critical PCB. Much testing is conducted on medical equipment, which is more than can be said for other kinds of PCB. This is primarily because of the stringent testing requirements imposed by regulatory agencies; however, functional testing and production testing are often also necessary. The regulatory testing that is required for medical devices usually falls into one of two broad categories:
- 実験室で使用されるような、患者に直接接続されない医療機器は、IEC 61010-1に該当します。
Ensuring the Reliability of Medical PCBA
Ensuring the production quality of medical PCBA is crucial. Before commencing large-scale production, it is essential to build prototypes of medical PCB to validate design feasibility and the manufacturer’s production capabilities. Continuous debugging and upgrades are performed to ensure that the product can meet industry standards.
The development process of medical devices is influenced by various potential risks. In addition to using more testing to ensure quality, it is also necessary to adhere to industry guidelines. Below are the industry standards that FS Technology recommends paying attention to during development:
- ISO 9000 or 9001: Addresses the quality and dependability criteria in designing, manufacturing, and testing electronic products.
- ISO 13485: This is a quality management system (QMS) standard specifically designed for medical device manufacturers. It sets requirements for the entire product life cycle, from design and development to production and post-market surveillance.
- IEC 60601: This is a series of international standards that cover the safety and effectiveness of medical electrical equipment. Particular attention is given to protection against electric shock, mechanical hazards, and radiation.
- IEC 61010-1: Safety rules for measuring, controlling, and lab equipment that uses electricity.
- IPC-A-610: This is a standard for the acceptability of electronic assemblies, including PCB. It covers requirements for soldering, cleanliness, and other aspects of production.
- FDA 21 CFR Part 820: This regulation from the US Food and Drug Administration (FDA) outlines the QMS requirements for medical device manufacturers. It covers areas such as design controls, production controls, and device labeling.
- UL 94: This is a flammability standard for materials used in electronic products, including PCB. It sets requirements for the resistance of materials to flame and ignition.
- CFR 820: For verifying production and quality control.
Focus of Project
- Choose a professional 医療用PCBアセンブリ工場 or a company with medical industry service experience and a good reputation to ensure the quality of PCBアセンブリサービス.
- を使用しています。 鉛フリーPCBアセンブリ が効率的とされ、サステナビリティに熱心な企業を選択することで、プロジェクトに思わぬメリットをもたらすことがあります。
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