Technology keeps advancing in our world today. All industries are profiting from this advancement. Even the medical industry isn’t left behind. Today’s medical devices are well-designed to meet the increasing demands of people. Some of these devices are small, yet they are powerful. The advancement in technology aids the manufacturing of compact and complex devices.
Furthermore, in the medical industry, precision and quality are key when it comes to PCBs. Circuit boards are the foundation on which these devices are built. Therefore, there is a need to pay more attention to PCBs used for medical devices. This article provides detailed information and knowledge on medical device PCBs.
What is a Medical PCB?
A medical PCB is a circuit board used for designing medical devices. This PCB enables the development of medical gadgets and devices. A medical PCB is the backbone of most medical devices. This PCB is specifically designed to meet medical instrumentation needs. Also, a PCB manufacturer must design a medical PCB with precision and reliability in mind. This is because medical devices are very critical. These devices save lives.
Furthermore, the function of a medical PCB is to integrate the electronic component into a space. This circuit board insulates the electronic components, making the devices safe for humans. A medical device PCB contains a wide range of electronic components. These components include connectors, capacitors, and more. Medical circuit boards provide electrical connection and mechanical support to components.
Generally, PCBs hold electronic circuits together. Also, the electroplated copper conductors pass through holes. Medical PCBs feature high-end and high-performance features.
Considerations for Medical Device PCB Fabrication
Medical devices are very delicate since they save human lives. Therefore, the medical industry emphasizes precision and quality during medical PCBs fabrication. However, there are certain design considerations for medical devices.
This is the first factor a medical PCB manufacturer must consider. Medical devices must be safe for use. Also, these devices must be well-designed to prevent any type of shock. Therefore when designing a medical PCB, you must put safety to mind.
Regardless of what the medical device is ideally meant for, precision is very crucial. Medical PCB manufacturers should determine the accuracy levels of their PCBs. Since medical devices are specifically designed for lifesaving purposes, precision is key. Also, manufacturers should design medical PCBs to survive dangerous environments.
It is very important to determine the marginal cases of the project application environment of a medical device. Which temperature does this PCB perform optimally? What happens when the device gets interrupted while working? It is important to consider these things when designing a medical PCB.
This is a crucial factor when designing medical device PCBs. Manufacturers should consider the life span of the PCB. Also, a medical PCB will influence the functionality and lifespan of a medical device.
According to industry standards, medical devices are class 3 electronics. This means that these devices must be well-designed to meet strict standards. Also, medical PCB fabrication must meet class 3 electronics requirements.
Common PCBs Used in Medical Devices
Not all types of PCBs can be used to fabricate medical devices. This is because these devices are very sensitive and delicate. Below are some common PCBs used in designing medical devices.
This is an excellent option for medical devices that have high thermal conductivity. Ceramic PCB can function in very high temperatures. Also, this PCB is ideal for circuits with a low coefficient of thermal expansion.
A flexible PCB is an ideal choice for most medical devices. This is because users place medical devices in locations that require flexibility. Also, flex PCBs have malleable nature which makes them suitable for medical devices. For instance, some medical wearable devices feature flex PCBs. Devices that require you to fold or wrap them will require flex PCBs.
This type of PCB features the durability of a rigid PCB and the malleability of flex circuits. Rigid-flex PCB combines the properties of rigid PCBs and flexible PCBs. Furthermore, manufacturers place the flexible material in between the rigid layers. Rigid-flex boards are more durable than flex boards. Also, these boards feature more design versatility as it durable and lightweight.
Flexible aluminum PCB
A flex PCB might meet the demands of some medical electronic projects. However, some high power medical devices require more powerful boards. Furthermore, a flexible aluminum board is ideal for high-power applications. This is because of its heat transfer properties. Also, you will find this board in surgical lighting and scanning devices.
A Polyimide PCB has great tensile flexibility and strength. This PCB material is very durable and chemical-resistant. These features make it ideal for some medical applications like implants and prosthetics.
Applications of Medical PCB
Medical PCBs are a core part of the evolution of modern medical devices. In modern health care, innovation keeps expanding. Also, the increasing role of new technology is apparent.
Wearable medical devices
People now wear medical devices. The production of wearable devices is expanding at a great percentage. Also, wearable medical devices are fitness trackers, blood pressure monitors, and smart health watches.
Medical PCBs are available in scanning devices. Ultrasonic scans, CT scanners, and X-ray screens feature medical PCBs. Also, the computers that analyze the images captured by these scanners feature PCBs.
Electronic health records (EHRs)
The electronic health record system was not well-integrated. EHRs take a bold step to consolidate patient details. Also, this record system can help to collect data on a particular population. This helps carefully study the success rate of treatment and medicine.
Of recent, hospitals have been using instant message apps and walkie-talkies. These devices have replaced overhead PA systems and beepers. In addition, there are now systems to convey messages and alerts in hospitals.
Implantable medical devices
Medical PCBs are a core component of implantable medical devices. Cochlear implants and defibrillators feature medical PCBs. For instance, the cochlear implant enables people with hearing impairment to process sounds. In addition, the responsive neurostimulator is planted in the brain. It helps to monitor brain activity in epileptics.
Medical boards play significant roles in monitoring devices used in healthcare systems. Furthermore, blood glucose monitors and bodily temperature monitors are an example of monitoring devices.
Which Mounting Technology is Ideal for Medical PCB Assembly?
The surface mount technology is ideal for medical PCB assembly. This mounting technique allows the placement of components on the PCB surface. Also, these components are surface-mount devices. In this mounting technique, there is no need for through holes.
One of the greatest advantages of SMT is that it enables automation. It is easier to use automation than soldering leads via tiny holes. The SMT process is very fast and reliable. Also, SMT doesn’t require drilling many holes.
This mounting technology is more affordable than the through-hole method. In a surface mount technology, components can stay on any side of the PCB. Also, components take less space. This is because these components are smaller than through-hole components.
Surface mount technology is also ideal for complex and compact PCBs. Therefore, SMT is great for producing some complex and compact medical devices. Furthermore, SMT PCBs can withstand constant motion and vibration more than THT PCBs.
What to Look Out for in a Medical PCB Manufacturer
Medical electronic devices require a high level of accuracy and precision. Therefore, medical PCB manufacturers should work towards ensuring quality control. If a medical device features a PCB, engineers need to pay more attention.
There are several medical PCB manufacturers available. However, it is important to go for a reliable medical PCB manufacturing company. So, how do you choose a medical PCB manufacturer? You will need to consider some factors when choosing a medical PCB manufacturing company.
Quality is very crucial in the medical industry. Medical devices are specifically used for lifesaving purposes. Therefore, quality control is of great importance in PCB manufacturing. Choose a PCB manufacturer that strictly adheres to the regulatory requirements of medical PCB fabrication. The regulatory requirements help to offer quality products.
It is important you consider this factor when choosing a medical PCB manufacturer. Experience is key. It makes a manufacturer better. You can inquire about the number of years the company has been in existence. How much work has it done in the past?
This refers to the period it takes to complete a particular order. Manufacturers who offer quick lead time will charge more. However, choose a manufacturer that never compromises quality for anything.
Your budget will determine the medical PCB manufacturer to opt for. Some manufacturers charge heavily for medical PCB fabrication. Some fabricate PCBs at affordable rates. However, regardless of your budget, always consider precision and quality.
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Manufacturing Standards and Regulations for Medical PCBs
Medical device PCB design is a complex one. Failure in medical devices can cause more harm. A patient can die as a result of this. Authorities such as FDA, IPC, and ISO have some standards for medical device PCB design. It is important to follow these standards and regulations.
The food and drug administration (FDA) imposes laws on companies that design medical devices. The FDA’s center for devices and radiological health (CDRH) monitors electronic devices. According to FDA, medical devices are in three categories. These are Class 1, Class 2, and Class 3.
Class 1 medical electronics are low-risk devices. They include IV stand, adhesive bandages, and sunglasses. Class 2 consists of intermediate-risk instruments. Class 3 medical electronics comprises high risk devices. They include ultrasonic scans and implantable neuromuscular stimulators. Medical PCBs must meet Class 3 electronics standards.
IPC regulates the fabrication and assembly standards of components. There are various IPC standards for medical device PCB. The IPC-A-600 standard defines the acceptability of medical PCBs. The IPC-A-610 defines the acceptability of assemblies. The IPC-A-6012 defines the performance and functionality requirements for circuit boards. The IPC 6011 standard defines the performance specifications for medical PCBs.
The International Organization for Standardization (ISO) releases different standards. These standards talk about the fabrication, testing, and design of medical PCBs. ISO 9000 standards ensure the safety of medical equipment PCBs and their function. The ISO 14971:2007 standard specifies how to identify any hazard in medical devices.
All these standards will help you achieve quality medical device PCB design. An experienced and reliable medical PCB manufacturer will adhere to these standards and regulations.
Quality Management in Medical PCBs
The ISO 13485 is a vital standard for PCB manufacturers. This standard decides quality management and control for medical devices. It works in line with other ISO standards to specify the quality requirement for medical devices. The ISO 13485 specifies the criteria for tracking all the components and materials in PCB manufacturing. Here are critical highlights of ISO 13485
- Process analysis
- Awareness and promotion of other regulations
- Design control and risk management
- Quality control processes
A quality management system specifies the policies and processes for designing a device. The ISO issued a standard known as 13485:2016.
Design Rules for Medical Device PCBs
Heavy copper and high currents
Designers need to increase the copper thickness to decrease trace resistance. High currents can produce high temperatures via joule heating. Using thinner traces offsets the marginal cost of using heavy copper. The IPC-2152 provides smaller copper weights and trace widths for medical boards.
Low EMI design
Fingertip pulse oximeters and wireless heart monitors have a narrow range of ISM frequencies. These devices compete for bandwidth. Therefore, designers must regulate the communications to avoid any interference with devices. It is very crucial to reduce unintended emissions resulting from poor layout practices. A pulse oximeter PCB requires low EMI design.
This is one of the most important design considerations for medical PCBs. Several layout practices can help your device pass compatibility testing.
Medical PCB fabrication is a very crucial process. This is because medical devices are very critical. Also, these devices are lifesaving; hence, the need for serious attention during manufacturing. For instance, the PCB for oxygen concentrators require high-performance features. Most medical devices are class 3 electronics. Therefore, there is a need for quality control in fabricating medical equipment PCBs.