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Challenges and Requirements of Medical PCB Assembly Discussed

 Sep 28, 2021

 Medical PCB Assembly

Medical printed circuit boards (PCBs) are in focus as they are being used in a large number of medical devices such as body temperature monitors, blood pressure monitors, blood glucose monitors, and so on. The importance of these PCBs has increased during the pandemic as they are used in various equipment designed for testing body fluids. Although there is a high demand for these PCBs, the manufacturers often fail to meet the deadlines due to supply chain delays or the lack of resources. In addition to these, there are several requirements they have to meet and even more challenges to address. This post introduces you to specific requirements and challenges of medical PCB assemblies.

Common Challenges of Medical Printed Circuit Board Assembly and Manufacturing

Precision and high quality are two important requirements for medical printed circuit boards. This can be achieved only if manufacturers follow a tightly controlled process with all right considerations of techniques, components, and materials. Along with these, manufacturers also need to address the following challenges:

  • Increasing Use of Mixed Technology Components: Like any other regular assembly, the medical PCBs may also feature both through-hole and surface mount components. Many manufacturers use these mixed assembly components to reduce the time of manufacturing. Although this technique may bring desired results, it increases the costs of manufacturing. Thus, using mixed technologies only when required and increasing the focus on SMT placement is recommended.
  • Over-tolerances: There is a common misconception that all medical devices fitted with PCBs may require tight tolerances. However, that is not true. Many designs can tolerate 5% to 10% resistors, and manufacturers can leverage this flexibility to the best of their advantage. It is the discretion of the contract manufacturer to understand how much tolerances are required for the PCB, else it may increase the prices of manufacturing and efforts, too.
  • Sensitive Components: Many medical PCBs utilize sensitive components with varying heat tolerances. If not chosen properly they may give up under high temperatures in Restriction of Hazardous Substances (RoHS) PCBA. Ensure the components are compatible with different reflow processes and temperatures in RoHS. Similarly, many medical equipment are regularly autoclaved and cleaned to maintain their integrity and cleanliness. Many capacitors, switches, resistors, and connectors cannot withstand regular cleaning – such as autoclaving or washing. Choice of the wrong components may lead to the failure of the equipment. Thus, when choosing the components for medical PCB assembly, it is important to ensure their compatibility with autoclaving or washing.

Requirements for Medical PCB Assembly and Product Development

As said before, medical devices need to be designed with precision and have typical requirements. The following are a few requirements PCB assembly manufacturers need to meet to maintain their relavance in the industry.

  • Certifications: Inferior grade PCBs do not serve the purpose and they may hamper the performance of several lifesaving equipment. Thus, the medical industry’s product development is highly regulated. It requires manufacturers to possess certifications like ISO 13485, IPC-A-610, and some general certifications such as ISO 9001.
  • Traceability: This is achieved through documentation. It is important for medical device manufacturers to trace the materials and parts to meet the requirements of ISO 13485. They are required to document the entire process for future enhancements and re-designs whenever required.
  • Lead-free Manufacturing: The medical devices to be sold in Europe must meet the RoHS directive. Thus, it is important for medical devices manufacturers serving Europe to possess lead-free PCB manufacturing capabilities. They must avoid using lead-free solders.

There are several manufacturers involved in medical PCB manufacturing; however, it is important to ask their approach towards these challenges and compliance to requirements. Accelerated Assemblies specializes in the medical PCB assembly and manufacturing, and has been serving clients through the pandemic and from much before. All these years, the experts at the company have successfully addressed the challenges and met the requirements of the medical PCB design effectively.