PCBs in the Medical Field
The most critical requirements medical products demand are quality, repeatability, and reliability. For PCBs in the medical field, those three requirements must be fully and conscientiously practiced at the layout, fabrication, and assembly stages. At the same time, compliance with ISO 13485 not only complements those requirements, but also adds further muscle to assure quality, robustness, repeatability, traceability, and reliability.
ISO 13485 is all about the potential risks involved and mitigating these risks during and after the building of medical products. It is a specific ISO standard serving as a comprehensive management system for the design and manufacture of medical devices. Like other ISO standards, its focus is on continuous improvement in process and quality systems. Also, a main emphasis is placed on cleanliness procedures clearly listed as a medical product undergoes various development and production stages.