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Critical Factors to Consider When Making PCBs for Healthcare and Life Science Industry

 Oct 29, 2021

PCBs for Healthcare

Today’s healthcare and life science sectors have become sophisticated, demanding advanced electronic devices with the highest standards of quality, precision, and reliability. Starting from small wearable devices to full-body imaging systems, most of the modern equipment used in laboratories, hospitals, research, as well as other related fields require advanced circuitry. PCBs, which are the backbone of such circuitry has become an essential component of high-grade medical and life science equipment. The role of PCBs in healthcare and life science industries is huge, and it is only getting bigger with the rapidly growing technologies. Therefore, there is a growing need for specialized PCBs in these sectors that guarantee high-reliability and the best performance. This post is intended to discuss a few specific requirements of medical industry when it comes to PCBs they use in their critical applications.

Key Considerations for Medical Grade PCBs Explained

The PCBs for the medical sector must be designed and manufactured with greater accuracy, strict quality, and cleanliness standards to ensure the safety and well-being of patients. While making PCBs for equipment for treatment, research, or training purposes, the following factors must be strictly considered.

  • Safety: Be it PCB or any other mechanical devises, adhering to the utmost safety standards is of paramount importance when it comes to the healthcare and life science industries. Medical device assemblies that are used directly on or inside the patients are constantly exposed to bodily fluids, liquids, shock or extreme pressure and temperatures. A poor-quality PCBs can bring circuitry malfunction and thus can pose danger to the patients and the users.
  • Cleanliness and Quality of Work Environment: Medical grade PCBs must be designed, manufactured and assembled in an extremely cleaned environments. If cleanliness is not maintained, there are high chances that residues such as inorganic salts, acids, and other fluids can left behind the boards, leading to corrosion. The medical devices thus degrade over time and potentially fail without warning. Hence, keeping the temperature, pressure, moisture, and air quality at the desired level matters to produce high quality medical grade boards.
  • Ability to withstand Disinfecting and Cleaning: Medical equipment are sanitized to maintain their cleanliness. Often they get smeared with various contaminants. Disinfection and cleaning helps get rid of pathogens, dust, bodily fluids and other contaminants that come in regular contact with the machines. Considering this requirement, medical grade PCBs must be manufactured utilizing materials that can withstand the regular cleaning procedures.
  • Materials: Material selection plays a critical role in medical grade PCB manufacturing as it impacts the thermal behavior, and the electrical and mechanical characteristics of the circuit. A few popular choices of materials for PCBs used in healthcare and life science sectors include FR-4, FR-4 high Tg, CEM-1, Teflon, PTFE, Polyimide, PEEK, Ro 3000, and RO 4000, among others. The boards are coated with a combination of Tin and Lead, Nickel and gold for added protection as per the application requirements.
  • Adherence to Standards: Almost all the medical devices and equipment are classified under Class 3 electronics. Hence, they must be designed and manufactured by stringently following all relevant regulatory requirements, be it in design, function, production, quality system, etc. Food and Drug Administration (FDA), International Organization for Standardization (ISO) certifications, Institute of Interconnecting and Packaging Electronic Circuits (IPC) are a few popular applicable standards in healthcare and life science PCB designing, manufacturing and inspection.

Application Examples of Medical Grade PCBs

Applications of medical PCBs are continually growing. They are the vital component in the following equipment and systems:

  • Blood Glucose Monitors
  • Blood Pressure Monitors
  • Body Temperature Monitors
  • Computed Tomography (CT)
  • Ventilators
  • Sterilization Equipment
  • Medical Testing Equipment
  • Blood glucose monitors
  • X-ray computed tomography
  • Heart monitors
  • Artificial Heart Pacemakers
  • Electrical Muscle Stimulation Equipment
  • Flow Rate & Dispensing Systems
  • Heart Monitors
  • Magnetic Resonance Imaging (MRI)
  • Imaging Systems
  • Ultrasonic Equipment
  • Vital Sign Monitoring Systems
  • X-ray Computed Tomography
  • Heart pacemakers
  • Ultrasound equipment
  • EMG activity systems
  • Peristaltic infusion technology
  • Flow rate and dispensing systems

Overall, high-quality PCBs are an integral part of the electronic devices used in the healthcare and life science industry. In order to ensure such stringent quality and precision requirements, it is important to get the designing, manufacturing and assembling done from an experienced manufacturer like Accelerated Assemblies. With several years of experience in Surface-Mount Technology (SMT) Manufacturing, Through-Hole Manufacturing, electronic assembly, box build PCB assembly, testing and inspection, Accelerated Assemblies has been serving the medical industry’s stringent demands most efficaciously. The manufacturer has experience and expertise in working with high-speed laminates, copper and aluminum substrates, ceramics, and specialized coating, which enable them provide reliable and long-lasting boards in the medical industry.

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