Medical PCB Assembly and Manufacturing

PCBAs have made it possible for machines to improve, so they are an essential part of our world today. Even though printed circuit boards are used in many electronic devices in modern life, like LED, water dispenser and air conditioner, their use in medical PCBs are one of the most cutting-edge applications.

With the development of the medical industry, China has gradually transformed from traditional Chinese medicine to western medicine, which has gradually increased the demand for electronic products in the medical industry, and China’s medical PCBA manufacturing technology has also developed. Today, almost all medical devices require medical printed circuit boards (PCBs). Because implants require accuracy, making and putting together these PCBs involves many steps and requirements.

Since you are reading this, we can only assume that you are curious about the production and assembly of medical printed circuit boards (PCBs). Without further ado, let’s roll the dice on this topic!

FS Technology Manufacturable Medical PCBA

If you’re looking for a top-tier manufacturer of medical PCBs/PCBAs, go no further than FS Technology. FS Technology is the clear leader in the industry when it comes to making and assembly medical printed circuit boards (PCBs). Two benefits of FS Tech’s medical PCB manufacturing services are quality compliance and competitive pricing. As a reliable medical device PCB manufacturer, we can build high-quality circuit boards according to customers’ PCB specifications. The following are some medical products we can manufacture (circuit boards or finished products):

Medical equipment using PCBA

Medical Device PCB Manufacturing

It is necessary to first create a medical PCB prototype before beginning production of the board in significant numbers. The PCB maker can more accurately indicate the board’s success level with the prototype’s aid.  As a result, several designs and manufacturing tweaks are carried out to generate a final PCB that satisfies the standard standards of the medical industry. This helps to prevent losses during mass manufacturing, making production more efficient and cost-effective.

For products such as medical equipment PCBs that directly affect the health of patients, FS Technology has been completing such orders with the strictest standards. The following is the manufacturing process of medical circuit boards:

Step 1: Electronic Medical PCB Schematic Design

Making a schematic design is the first step in manufacturing and assembling a medical PCB. Here, the client gives all the essential information about the PCB to the medical PCB manufacturer, which is used to make the basic drawings. Some of the important details here are how the PCB will be used, what kind of PCB it will be, how much power it will need, and what materials will be used. All of these details must be correct, and the first design of the medical PCB must be based on them.

Step 2: Layout planning of medical electronic components

PCB component (SMD and DIP) placement planning follows the completion of the virtual schematic diagram. With its aid, we may calculate the number of PCB layers and other technical requirements.

Component placement guarantees error-free medical PCBA fabrication as well. Making a printed circuit board in this way reduces manufacturing costs generally. 

Step 3: Medical device PCB design

The following phase, which comes after the initial design of the schematic, is to produce a layout for the medical printed circuit board (PCB).

To avoid board-level failures, use professional PCB design tools and follow good PCB layout practices for this process. In the case of medical devices, people’s lives depend on how well the PCB works, so it’s not just a good idea to follow best practices; it’s a must. The following are considerations for designing medical PCBs:

  • Keeping trace lengths as short and direct as possible is one of the best practices for medical PCB devices.
  • Use power planes and ground planes to shorten the signals from decoupling capacitors and cover the ground well.
  • Build high-energy traces and planes with enough copper to handle a lot of power and as little voltage drop as possible.
  • Use differential pairs or signals to cut down on reflection for high-speed data traces.
  • To stop cross-talk, keep clock signals short and away from other nearby trails or planes.
  •  If you have to overlap traces from different layers, do it as perpendicularly as possible.
  • Keep components that are sensitive to temperature away from other components.
  • Always check the reflow soldering requirements twice to ensure that some SMD parts stay cool while being put together.

Step 4: Files for final work

Sending Gerber or CAD data to China medical PCB assembly manufacturer is the last step in design. You can now send the files and instructions listed above to the company that makes your PCB board.

When your final manufacturing files are sent to the manufacturer, and your PCB design is approved, fabrication or manufacturing can start. This converts your digitally-designed printed circuit board into a real one.

While there are many PCBA manufacturers across the globe to pick from, FS Technology is unquestionably the finest and most experienced service provider for medical PCB projects. We’re the most cost-effective option since we provide a more extensive service.

Step 4: Design imaging

The medical PCB manufacturing factory starts to intervene in the work from this step. Your medical electronics PCB board maker uses a plotter printer to turn the design files for circuit boards into films. These films are similar to the photo negatives of your diagram.

When the PCB is printed, the inside layers have two colors of ink:

  • Black ink stands for the copper traces and circuits on the PCB. 
  • Clear ink, like the fiberglass base, stands for the PCB parts that don’t conduct electricity.
 

The outer layer has:

  • Copper pathways that are shown by clear ink
  • The area where the copper will be etched away is marked in black ink.

Step 5: Printing copper on the board's inner layers

This step in making a PCB marks the start of making the PCB itself. The procedure starts with the primary form of a PCB, which is a laminate board made from the substrate material. Usually, epoxy resin and glass fiber are used as the base materials.

The PCB design is printed on the laminate board. Copper is bonded to both sides of the laminate board. The copper is then etched away, revealing the PCB design. The laminate board is then covered with a photosensitive film called the resist.

Step 6: Combining the different layers

After the laminate boards have been cleaned, they are ready for layer alignment. Most of the time, medical PCB makers use an optical punch, a machine that drives a pin through registration holes to line up the inner and outer layers.

Step 7: Drilling

Drilling is the most crucial step in making a Pacemaker PCB because it sets up the base for vias and the connections between the different PCB layers. Precision drill holes are needed for all parts that will be added later, like copper-linking via holes and lead-based parts.

Pacemaker PCB drilling requires the highest level of accuracy because even the slightest mistake can cost a lot of money. Drilling also takes time because a typical medical pacemaker PCB has more than a hundred drilling places.

Step 8: Medical PCB outer layer imaging

In this step of the PCB manufacturing process, another photoresist is again put on the PCB medical panel. For imaging, however, the photoresist is only put on the outer layer. The process takes place in an area that is clean and safe.

Pins hold black ink transparency sheets in place and keep them from getting out of line. The PCB medical panel goes into the yellow room after being coated with a photoresist. The UV light blast hardens the photoresist. The unhardened resist that is covered by black ink is removed.

Step 9: Outer layer etching

During this process, copper that doesn’t belong in the outer layers is removed. Electroplating is used to add a layer of copper. Tin electroplating protects copper in the critical area after the first copper baths. After the outer layer has been etched, the PCB panel is ready for Automated Optical Inspection and soldering. The medical beauty PCB board goes through Automated Optical Inspection (AOI) to ensure the copper layer meets the specifications.

Step 10: Solder mask

After that, we apply the solder mask because it protects the outside of a medical printed circuit board and prepares it for the soldering process. It hides the parts that don’t need to be soldered.

The medical PCB panel is cleaned to eliminate dirt or copper that doesn’t belong there. An ink epoxy and solder mask film are put on the surface. UV light blasting shows where soldering doesn’t need to happen. The solder mask is taken off of areas that don’t need it. The circuit board is put in an oven to cure the solder mask.

Step 11: Silk screening

The details are printed directly on the board with an ink-jet printer during silk screening. It usually consists of the Company ID, Manufacturer’s logo, symbols, component numbers, pin locators, and other distinguishing markings or features.

Step 12: Surface finishing

The nearly finished medical PCB panels need a coating of conductive material, usually done according to what the customer wants. This gives the PCB more room for soldiers. After this process, the surface will have a finish.

Difficulty and overcoming of Medical PCBA manufacturing

When compared to traditional PCBs, medicinal PCBs are notoriously difficult to manufacture. Manufacturers face the following difficulties:

  • Medical cosmetic PCB may incorporate through-hole and surface mount components, which raises production costs.
  • As a result of technological advancements, medical equipment has become ever more compact. Therefore, Miniaturization is one of the most challenging in Medical wearable device PCB assembly.
  • Medical defibrillator PCB often use heat-sensitive SMD electronic components. If not carefully selected, RoHS PCBA may fail at high temperatures. 
  • Mismatched parts may cause equipment failure. It’s crucial to use autoclavable or washable components for cheap medical PCB assembly.

Types of Medical PCB

Medical HDI PCB:

HDI PCBs, “high-density interconnect printed circuit boards,” are one of the most common types of printed circuit boards used in advanced medical devices today. Because the medical HDI circuits, ensures high-speed data transfer, it is the board most desired in most medical equipment. Even though they are a little bit of price, they are essential for critical medical diagnostic devices, where the response times of the device could mean the difference between a patient surviving or dying.

As a result of their resistance to electromagnetic interference and noise, high-density printed circuit boards (PCBs) are used in most medical equipment. Most medical CT Scans equipment, such as multi-modal physiological and ECG monitors, can use the real floating-point input made possible by the high-density connectivity of HDI PCBs. This input may also facilitate faster communication.

Medical Flex PCBs:

Flex PCBs are in high demand in the medical device industry because they provide more design freedom in addition to being more flexible than traditional PCBs. A medical flexible printed circuit board, often known as a “medical flex PCB,” is a patterned arrangement of printed circuitry components that uses flexible-based material (FPC), either with or without a flexible substrate.

Designs for flexible PCBs are increasingly significant in the medical device sector. There are a lot of different devices that may use durable boards that provide them with high-quality performance without any interruptions so that they can extend people’s lives or cure diseases.

They are constructed to survive shifts in temperature, as well as being watertight, sterile, and capable of being reassembled several times.

Medical Rigid PCBs

The medical sector extensively uses rigid Printed Circuit Boards, unlike flexible PCBs since they are solid and inflexible. The x-ray machine, the incubator, the defibrillator monitor, the ECG machine, the chemotherapy pump, and many more medical devices are prime examples.

Medical equipment is among the essential supplies in a healthcare facility. Because of the potential threat to human life, they must be devoid of errors. Because of this, the majority of firms that manufacture medical devices choose to employ rigid PCBs rather than other types of PCBs.

There is a wide variety of rigid boards available, some of which include glass epoxy PCBs, aluminum core PCBs, and others. On the other hand, many medical devices choose to use multi-layer rigid PCBs because of the adaptability and variety of functions that these boards provide.

Standards for manufacturing medical PCBs

Potential hazards are rigorously monitored and assessed throughout the development process of medical devices. Several different types of testing are used to ensure conformity to these criteria. There are several standards that your electronic medical equipment may need to meet.

  • ISO 9000 or 9001: Addresses the quality and dependability criteria in designing, manufacturing, and testing electronic products.
  • ISO 13485: outlines the standards for tracking systems.
  • CFR 820: For verifying production and quality control.
  • US FDA 21 CFR: for companies that make, repackage, relabel, or import medical devices that are sold in the US.
  • IEC 60601-1: General standards for fundamental safety and necessary performance.
  • IEC 61010-1: Safety rules for measuring, controlling, and lab equipment that uses electricity.
  • IPC 6011: Generic Performance Specifications for Printed Boards.
  • ISO 13485: Requirements for regulatory quality management systems.
  • IPC-A-610: Addresses the acceptability of electronic assemblies.

Medical PCB Assembly

The complexity of medical printed circuit boards is proportional to the number of processes involved in making them. The functionality of the PCBA may be compromised if any of the steps in the process are skipped or shortened. However, once the medical PCB assembly process is complete, these assembled PCBAs will be able to perform their intended functions. Next we will show the assembly process of these high-end medical electronic devices:

Step 1: Solder paste stenciling

The solder paste stenciling technique is the first stage in the assembly procedure. In this step, the circuit board is covered with a stencil so that just the portion of the PCB board that would 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.

A mechanical device is used to hold the board and the solder stencil in place so that we may accomplish this. Following that, an applicator is used to deposit the solder paste at the predetermined locations. The solder paste is applied consistently over all of the exposed regions. After this step, the stencil is removed, and the solder paste is left in the appropriate locations.

Step 2: A Game of “Pick and Place”

Accurate mounting of the numerous electronic components that make up the medical cochlear implants PCB occurs in this area. To achieve the high level of precision required for the assembly of medical cochlear implants PCB, a robotic device is often used for this task. The robot is responsible for picking up and installing surface mount components on the board. The components are precisely placed on the solder paste thanks to the mounting mechanism.

Step 3: Soldering Reflow

The soldering overflow process aims to strengthen the connections between the circuit board and the electrical components. To accomplish this goal, a conveyor belt is used to transport the circuit board through a large reflow oven. The solder paste is melted by heating the PCB to around 2500 degrees Celsius during the procedure. After being heated in an oven, a medical PCB goes through a series of coolers, which help the solder paste cool and harden, resulting in solid connections between the component components and the board.

It is essential to remember that the stenciling and reflowing processes for double-layered medical PCBs are carried out in a distinct order. The device side with fewer and more manageable electrical components is completed first.

Step 4: Medical PCB Assembly Test

After the medical device’s printed circuit board (PCB) has been built, it is examined to look for and fix any faults or problems with the connection that movements may have caused during the reflow process. Manual inspection, X-ray inspection and automated optical inspection are the PCBA tests that FS Technology will perform

Step 5: Medical PCB Functionality test

In the last stage of assembling Medical PCBs, the produced board is subjected to inspection and testing. In this section, a comprehensive functionality test is carried out to guarantee that the board functions as expected and is up to the high requirements set by the medical industry. After the board has been examined, we will clean it to eliminate any oil, flux, and other types of waste that may be on it. This ensures that the medical board is sterile and may be used to produce medical devices. It is possible to conduct specialized testing on the Medical PCB following the particular kind of medical equipment that will be using the board.

Points to pay attention to when assembling medical PCB

Whether they are used in the operating room or the lab, all medical PCB applications need to be 100% reliable. No one in the medical field has time to deal with equipment malfunctioning or performing incorrectly. Following PCB assembly practices are essential when creating a circuit board for use in medical devices:

  • It is fundamental to find the best possible components and use them.
  • It is essential to position components carefully and routes traces to make a board successfully.
  • Make sure that electromagnetic interference won’t mess with it.
  • Engineers should look at several EMI standards, starting with IEC 60601-1-2. A PCB CM should have ISO 9000 or 9001 certification. This standard discusses the quality and reliability requirements for designing, building, and testing electronics.
  • The PCB you use to make your medical electronics must have a good reputation and be able to create high-quality circuit boards.
  • Your medical PCB should use a lead-free manufacturing process separate from their normal soldering processes when making your medical equipment.

Strict medical PCB testing

The development process for medical devices includes extra considerations and requirements beyond what is generally required for creating non-critical PCBs. Much testing is conducted on medical equipment, which is more than can be said for other kinds of PCBs. 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:

  • Medical equipment that either transfers energy to or from a patient or detects energy transmitted to or from a patient is the focus of IEC Standard 60601-1.
  • Medical equipment not connected directly to a patient, such as that used in a laboratory, falls within the IEC 61010-1

The above is all about “Medical PCB Manufacturing and Assembly”. If you recognize our manufacturing capabilities and expect to get a quotation for Medical PCBA, please contact us through the above email, and our sales will provide you with a price list.

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