The terms “quality,” “repeatability,” and “reliability” are inextricably intertwined for medical electronics PCBs. There’s absolutely no question that these requirements must be woven into design and manufacture practices.
They take on new meaning today as tiny boards move into a growing number of wearable devices. Many of them are medical electronics devices created to help healthcare professionals be more efficient and patients to monitor their well-being.
Those three requirements must be fully and conscientiously practiced at 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.
View our article in Medical Design Briefs Magazine to get a more comprehensive story on the importance of quality, repeatability, and reliability for medical electronics PCB.
- Shown in Fig. 1, proper splitting of power and ground planes is vital to reduce noise and crosstalk.
- High signal-to-noise ratios (SNR) are highly undesirable in medical electronics designs to prevent erroneous signals, incorrect equipment readings, and patient diagnosis.
- Use as many ground layers as possible to suppress noise and keep SNR in check to a desirable level.
- Closely collaborate with PCB designer to assure BOM includes component availability and correct tolerance levels.
- Get with the PCB designer to assure proper amount of test points to assure DFT.
- Work with your EMS Provider to define a battery of tests to make your medical PCB foolproof and safe in the field.
Lastly, an exemplary rule-of-thumb is to make sure your EMS Provider or Contract Manufacturer has a disciplined program in place to monitor and catch even the most minor miscue. Those miscues can have devastating consequences.
They can occur either at assembly or even later on as latent defects in the field. Therefore, it’s good practice to have an extra set of eyes ready and willing to check all critical aspects of a layout. For example, that extra set of eyes double checks on assuring proper component footprints and polarities, making sure a silk screen is correctly associated with a given component, and pin numbers and sequencing are accurate for complex components.