Transformative Breakthroughs in Medical PCB Technology Reshaping the Healthcare Landscape
In the rapidly evolving field of medical electronics, safety and efficiency are paramount. This article explores the key regulations and standards that govern the design and development of medical electronics, ensuring they meet the highest safety and performance standards.
Medical PCBs, a crucial component in various medical devices, are often high-density interconnects (HDI PCBs) that fit the unique constraints of medical devices. They have played a significant role in transforming the way we live and die, making misjudgments in medical situations less likely.
One of the primary standards for medical electronics is the International Electrotechnical Commission (IEC) 60601 series. These standards cover the safety, essential performance, and electromagnetic compatibility of medical electrical equipment. IEC 60601-1, in particular, focuses on the basic safety and essential performance requirements for electrical devices powering medical equipment.
Another essential standard is ISO 14971, which addresses risk management throughout all stages of a medical device's life-cycle. Given the safety-critical nature of medical electronics, risk management is crucial to ensure the safety and effectiveness of medical devices.
ISO 13485:2016 is another vital standard in the medical devices industry, focusing on Quality Management Systems (QMS). This standard applies universally across manufacturers and suppliers of medical devices, forming the basis for regulatory compliance worldwide.
The Food and Drug Administration (FDA) in the US also plays a significant role in regulating medical electronics. All manufacturers, distributors, repackagers, relabelers, specification developers, reprocessors of single-use devices, importers, and exporters must register their organization with the FDA. The Center for Devices and Radiological Health (CDRH) regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Regulatory frameworks such as the EU Medical Device Regulation (MDR) 2017/745 and FDA’s 21 CFR 820 Subchapter H on quality system requirements including design controls have also been implemented to ensure manufacturing and design controls enforce consistent quality and performance.
While the most widely used textbook in this field is over 14 years old, the slow pace of fundamental changes in the underlying principles of medical electronics design, combined with the rigorous and lengthy regulatory update cycles, contributes to this. However, comprehensive textbooks often take years to draft, review, and gain broad acceptance, and updates may lag behind the rapid regulatory amendments and technological advances reflected mostly in standards documents and guidance rather than academic texts.
Research is also being conducted to form a skin with sensing capabilities, and the term "micro-miniaturization" is used in the PCB market for the delivery of pharmaceuticals via implanted electronics, known as "electroceuticals."
In summary, medical electronics design is governed by internationally recognized standards and regulations focusing on quality, safety, risk, and performance, which are periodically updated. Widely used textbooks remain older because they cover enduring foundational knowledge rather than frequently changing regulatory specifics.
Science plays a significant role in the development of medical electronics, contributing to the improvement of health-and-wellness by reducing misjudgments in medical situations. Risk management, according to the ISO 14971 standard, is essential to ensure the safety and effectiveness of medical devices in dealing with medical-conditions.
