Fee standard: One of the main issues with medical PCBs is cost. The development and production of medical PCBs can sometimes be costly. This is particularly suitable for small batch applications. The regulations for medical PCBs stipulate that the total production cost of the electronic manufacturing industry is the total cost.
Reliability issue: Although medical circuit boards are very reliable, they are still prone to failure due to factors such as component degradation, environmental factors, and mechanical problems. These faults are very serious as they may pose a risk to patient safety.
Interference issue: Medical equipment PCBs may sometimes be susceptible to electromagnetic interference from nearby medical electronic devices. This may affect its performance and accuracy. In addition, maintaining electromagnetic compatibility (EMC) standards may be challenging for these medical devices.
Long development cycle: Due to the need for PCB testing and validation according to regulatory guidelines, the time to market will be extended. Before distribution, regulations including ISO 13485 and FDA guidelines must be met.
Limited flexibility: It is difficult to make changes or upgrades to medical PCBs after they are put into the market, which makes the flexibility of medical PCBs in terms of technological progress in the medical system relatively low.
Material selection: Choosing the appropriate medical PCB material is very important because the selected material has high performance and reliability, and must also comply with regulatory standards. Sometimes, choosing the right materials can be a challenge as the materials must meet both electrical and biocompatibility requirements, which may limit the diversity of design choices.
Security risks: With the rapid increase in connectivity of medical devices, people's concerns about network security risks are growing. This is particularly applicable to networked devices or medical devices that support the Internet of Things. These devices are vulnerable to hacker attacks and unauthorized access, which may result in damage to patient data or the functionality of the devices used.
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Haibo is an expert in the field of FPC/PCB manufacturing and surface mount assembly in China. Since our establishment in 2017, we have been providing high-quality PCBs to over 1000 customers worldwide. Our factory has passed ISO14001, ISO9001:2015, TS16949, and ISO13485:2016 certifications. We are one of the most trusted small and medium-sized FPC/PCB manufacturers in China.
