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PCBs for Medical Equipment

In many ways, technology has reshaped our world, but the most significant impact has been in the field of medicine. PCBs are crucial components in the medical device industry, enabling the functionality of a wide array of medical instruments and equipment. 

Here are some of the most important features of PCB for medical equipment; we hope this information will help you learn more about Medical PCB and how to pick the right one for your medical devices.

Table of Contents

How to Choose The Suitable PCB for Medical

Compliance and Standards of PCB for Medical Devices

Choose Correct PCB for Medical Devices
  • ISO 13485 Certification: This indicates that PCBs meet the international standard for medical device quality management systems.
  • IPC Class 3 Standards: IPC-A-600,  IPC-A-6012, IPC-A-610. These dictate higher levels of reliability and quality control.
  • RoHS Compliance: Ensuring the PCB is RoHS (Restriction of Hazardous Substances) compliant is critical to avoid harmful substances.

Main Types of PCB for Medical Devices

  • Multilayer PCBs: They are used in very complicated medical equipment that require considerable functionality while being compact, such as MRI machines, CT scanners, and advanced medical imaging systems. Their numerous layers enable more circuits to be packed into a smaller space, improving the device’s usefulness and dependability.
  • Rigid-Flex PCBs: They Provide a versatile solution for complex medical devices that require rigid areas for certain components and flexible sections for connectivity or movement. This type of PCB is utilized in complex medical equipment such as pacemakers, portable medical devices, and devices with moving elements that require connections that can survive bending or folding.
  • Flexible PCBs (Flex PCBs): Made from flexible materials, these PCBs can bend or fold during use, making them ideal for medical devices that require flexibility or are subject to movement. They are often used in medical wearables, flexible medical instruments, and implants. Flex PCBs are particularly valued for their durability and the ability to fit into unconventional shapes.
  • FR-4 PCBs: By their low cost and relatively simple manufacture, FR-4 PCB has become the most common PCB laminate for many medical devices.

Key Consideration of Medical PCB Assembly

As medical devices are used in important health-related procedures like operations, these medical devices need to be accurate, reliable, and sustainable, and this is only possible by designing highly accurate and precise PCBs for that medical device. So, regardless of the type of medical device, a PCB must be designed, manufactured, and assembled correctly.

  • Safety:

It is the first consideration while manufacturing PCBA for medical devices, as those devices are either used on or inside the patient’s body. If there is any short-circuit happens during the operation then this may cause patient death. So, it is important to develop robust devices for medical purposes to ensure patient safety even when used under extreme conditions.

  • Reliability:

Reliability is another key consideration during the medical PCB assembly process that ensures the high performance of devices, which is also critical to ensure the device is performing as expected and delivering consistent results.

  • Regulatory Compliance:

Medical PCBs, unlike other PCBs, must meet strict standards to ensure their reliability and durability. As a result, it is important to understand and comply with all predefined standards and regulations to generate complete information regarding development procedures PCBA for that specific medical device whenever needed.

  • Improve Turnaround Time:

Medical device companies must develop new medical devices and bring them to market promptly. While PCB manufacturers determine the development timeline, experienced manufacturers know how to accelerate progress while maintaining the same level of efficiency or even improving it up to some extent. This means experienced PCBA manufacturers with t the b best turnaround time and h high-efficiency records must be selected to have a quick and highly efficient medical device.

  • Cleanliness:

During fabrication and soldering of medical PCBs, acids, inorganic salts, and other residues may sometimes be left on the PCB assemblies, which can lead to the corrosion of PCB components, causing electrical equipment to degrade and eventually leading to the failure of the device. To resolve this issue, it is important to clean the PCBA to ensure high standards and improve the reliability of the medical device.

Applications of Medical PCB

Implantable Devices

One of the most important components of implantable medical devices is medical PCB. Because of the precision of such medical devices, the manufacture and assembly of such PCBs must adhere to strict standards.

  • Cochlear Implant: These types of devices are used to help deaf people in hearing.
  • Implantable defibrillators: These medical devices help those people who have high heart disease risks from unexpected trauma.
  • Responsive Neurostimulator (RNS): It is a device that is implanted in the brain and is used by people who have epilepsy. People with epilepsy, do not respond well to seizures. These kinds of implanted medical devices continuously monitor brain activity and give electric shock whenever it detects abnormal brain activity.

Medical Imaging and Diagnostic Devices

Imaging Medical Devices

These types of medical devices are critical in the healthcare industry because they provide useful information to doctors and health-related professionals to diagnose and treat medical cases in a better and more efficient way. PCBs are found in a variety of medical imaging and diagnostic equipment, such as Magnetic Resonance Imaging (MRIs), ultrasound equipment, X-ray machines, and CT scans.

Monitoring Devices

Devices like blood pressure monitors, temperature monitors, blood glucose monitors, and respiration monitors are some examples of medical monitoring devices, and all these medical monitoring devices have one core component and that is PCBs. 

Another example of a life-sustaining device is a dialysis machine, which is essential to the survival of many patients. In summary, the electronics and PCB assembly sectors are heavily reliant on the manufacture of medical devices.

Testing Standards to be followed for Medical PCBs

It is good practice to do regular testing during the manufacturing of PCBA especially to ensure the reliability of medical devices.

  • Automated Optical Inspection (AOI): AOI uses a single 2D camera or two 3D cameras to capture images of the PCB. The captured image is checked against the schematic. If the board does not match the schematic, it is sent to be manually inspected.
  • Solderability Test: This test ensures whether the terminals and leads are soldered perfectly or whether there are some defects while soldering.
  • Ionic Contamination Testing: This testing is used to detect ionic residues that form during the fabrication of PCBs for medical devices and component soldering processes.
  • Peel Test: This test is used to determine how much force is required to peel the laminate from PCB.
  • Flying Probe Test: In this test, a probe moves to different testing points to test electronicsrelated problems like a short circuit.

Conclusion

The main purpose of developing electronic medical devices is to meet the needs of the medical industry. It is part of our common need, whether it is related to diagnosis or laboratory equipment. Some of these medical devices are becoming life-saving support to millions of patients across the globe like pacemakers. 

Are you looking for a dependable medical PCB manufacturer or PCB assembly service? Get a quick quote from ELE PCB now!

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ELE PCB has got the IS09001:2015, IS013485:2016, ROHS and FCC certifications. We can offer all kinds of services, including PCB manufacturing and PCB assembly, sample orders and batch orders. For PCB assembly, utilizing 7 high-speed SMT PCBA lines from Yamaha and Sony, to meet our customers’ needs. Our extended services include PCB design &PCB Layout, hardware design engineering, firmware &software development, and personalization. ELE company is honored as an excellent supplier from any company all around the world. We deeply believe that our good service and experience will completely meet your needs. Integrality, value and innovation are the forces that drive our success.

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