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How Crucial is High-Quality PCB Assembly for the Medical Industry?

How Crucial is High-Quality PCB Assembly for the Medical Industry?

Jul 25,2023

PCBs are extensively used in various diagnostic and research equipment used in the medical and healthcare industry. With increasing focus on patient outcomes and safety, the designs for these equipment are quick evolving. The roles of these PCBs is getting bigger by day. Medical PCBs are used in many medical equipment like pacemakers, medical imaging equipment, smart monitoring gadgets and devices, and so on. Although these PCBs may pass off like any industrial PCB, they are designed to meet a wide range of patient care settings, and testing scenarios. This post discusses why high-quality PCB assembly is crucial for the medical industry.

What Accounts for the Increasing Demand for Performance-Driven PCBs for Healthcare Sector?

As the medical industry continues to innovate and develop new treatments, medical devices must be able to keep up and adapt. PCBs are essential for creating the complex circuitry required for these new devices, and they allow manufacturers to design smaller, more efficient and more reliable medical equipment. Having path-breaking PCB solutions for the medical industry is highly significant for several reasons, which are listed below.

  • The utilization of superior-quality PCB assembly in medical equipment guarantees not only its safety but also its accuracy and reliability. This aspect holds immense importance as it has the potential to save lives.
  • The use of new advanced PCB solutions into medical equipment can also lead to new technological advancements in the field of healthcare. For instance, today’s modern medical devices enabled with IoT (Internet of Things) technology immensely support remote patient monitoring, real-time diagnoses, and even predictive analysis of medical conditions.
  • Today, several kinds of advanced-level PCBs are used during the production of medical research equipment, including DNA sequencers and microscopes. These machines need precise and dependable functioning, which is enabled by PCBs.
  • PCBs help to miniaturize and automate equipment, making it more portable and efficient.
 Critical Requirements of PCB Assembly in the Medical Industry

When it comes to the PCB assembly, the medical industry imposes several strict requirements, which must be followed to ensure that the final product is safe and effective for use in mission-critical medical applications. A few of the must-have requirements are as follows:

  • High Quality and Reliability: It is crucial to have dependable and secure PCBs that can endure demanding operating conditions and safeguard patient well-being. The PCB assemblies must be manufactured to the highest quality standards to ensure reliable performance.

  • Regulatory Compliance: In order to meet the necessary safety and quality requirements of the medical industry, medical PCBs must adhere to strict regulatory requirements set by organizations like the Food and Drug Administration (FDA) and other regulatory bodies. The PCB assemblies designed for medical devices must adhere to regulations, including documentation, design controls, traceability, and so on.

  • Component Selection: Quality of the PCB assembly in the medical industry depends on the material or components used. Thus, they must be chosen carefully. Polyimide and ceramic are two popular materials used. Polyimide materials are thermally stable, durable, and chemical resistant, thereby making them an ideal choice for implants and prosthetics. Ceramics are ideal for PCBs with high thermal conductivity and low coefficient of thermal expansion. They can withstand high temperatures. Ensure to source these materials from trusted and reliable suppliers that meet the necessary performance and compliance standards.

  • Testing and Validation: PCBs used in medical devices must be tested and validated to ensure that they meet the necessary performance and safety requirements. This includes testing for electrical performance, reliability, and durability using In-Circuit Test (ICT), Flying Probe Test and Functional Circuit Test, among others.  

  • Ability to Withstand Sterilization: Most medical devices are sterilized to ensure the safe use. Hence, the PCB assemblies must be designed such that they can withstand the sterilization, such as radiation sterilization, ethylene oxide (ETO) sterilization, and autoclaving.

  • ESD Protection: Unlike regular commercial equipment, the medical equipment have stringent electrostatic discharge requirements to prevent the damage of sensitive electronics. PCBs should be designed EMC compliant with adequate ESD protection measures, including ESD-safe handling, proper grounding, and so on.

  • Documentation: As said before, the medical industry follows stringent regulatory standards and requires comprehensive documentation.  So, everything right from the material traceability to the details of bills of materials (BOMs), assembly instructions, and revision control processes must be documented.

In conclusion, the significance of having path-breaking PCB solutions for the medical industry cannot be overstated. It enables the medical industry to continue to make significant strides in delivering higher-quality care while staying at the forefront of technological advancements. Being said this, as the healthcare industry demands precision and high quality when it comes to electronic and mechanical components, so it is highly recommended to associate with only trusted manufacturers like Creative Hi-Tech to get done with PCBs with the required specifications. Creative Hi-Tech has decades of experience in providing PCB assembly services for the medical industry, including mixed SMT, through hole technology in simple, double and multi-layer configurations as demanded by the medical industry. Get in touch with the team at Creative Hi-Tech and see what they can offer for your next medical-grade PCB project.

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