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.

PCB Design/Layout

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A number of critical factors must be taken into account at the PCB design layout stage. But the most prominent are checks and balances, split planes, component selection and cross referencing when needed, complete fabrication and assembly drawings, and test coverage on the board.

Major and minor checks and balances are especially important for medical electronics design. That’s because any error or miscue–even the most minor–can have devastating consequences. They can occur either at assembly or even later on as latent defects in the field. A good rule of thumb is to assume Murphy’s Law will prevail at some point during a design. Whatever can go wrong, will go wrong. 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.

Proper splitting of power and ground planes, as shown in Figure 1, is vital to reducing noise and crosstalk. Also, high or relatively high signal-to-noise ratios (SNR) are definitely undesirable in medical electronics designs. The reason is SNR can adversely affect signals, preventing correct medical equipment readings and subsequent patient diagnosis. PCB designers must also be aware of keeping noise-generating, high-frequency devices away from high-speed digital signals. Otherwise, unwanted noise has a negative impact on those high-speed digital signals.

Experience has shown that it’s best to use as many ground layers as possible in this instance. Those layers help to suppress noise and keep SNR in check. Adding more ground planes to a medical PCB design incurs a slightly higher cost, however, the added cost pays dividends in higher quality and reliability in the long run. Consequently, medical products designed with these extra ground layers don’t fail as frequently in the field as those with fewer ground layers.

Enlarge this picture Fig 2 Fab drawing showing complete notes to avoid confusion

As for component selection, OEMs are generally responsible for specifying components and associated parts during the design stages. But it’s always a good idea for the experienced PCB designer to work together with OEM designers to review the bill of materials (BOM) and make sure they’re using components with the correct level of tolerances, and that their availability is not an issue.

• For instance, in some cases, components with 2-5 percent tolerances should be used instead of those with 10 percent tolerances. Those components may come at an extra cost, however, like the extra ground layers, this added precaution helps to sustain higher quality and reliability in the long run.

Carefully selecting an alternate component is another important aspect at layout. Let’s say an OEM has selected a particular Xilinx part before, but now it’s unavailable or its cost doesn’t meet the design budget. At this point, the PCB designer should carefully study the alternate device to be used in place of the originally specified component, review its performance history and its results, along with the datasheets, and, in short, take a closer look to determine if it has higher failure rates than usual.

As layout is nearing completion, a comprehensive fabrication (Figure 2) and assembly drawing—which a PCB designer provides to avoid making costly guesses at the different stages of production of medical devices—is provided. Here, the PCB designer assures all revision (REV) levels are distinctly listed on all documents and if there are changes in the original design, the REV is rolled. Rolling the REV means assuring that a particular part of all documentation from the layout department is correctly released. It makes the life of the document control, as well as departments, really easy if REV levels are all properly assigned to fabrication and assembly drawings, ECOs, and so on.

Fig 3 Test point coverage using a flying probe tester

When it comes to the design-for-test (DfT) of a medical electronics design, the savvy PCB designer ensures an ample amount of test points are assigned for a board to ensure DfT. The larger the number of test points, the higher percentage of PCB testability, with the target being 80-90 percent and even higher coverage at different testing stages, such as flying probe testing (Figure 3).

With many medical devices becoming more compact and portable, the PCB designer runs into severe challenges when trying to place more test points on ever-shrinking board real estate. But the creative PCB designer isn’t stymied or discouraged in this regard and finds ways to resolve this issue by cleverly manipulating board area versus design criteria.

Also, in support of this PCB design practice, the prudent OEM working together with its EMS provider or contract manufacturer (CM) will define a battery of tests to make a medical PCB foolproof and safe in the field. A best practice like this helps ensure that an OEM’s medical product is highly reliable and not prone to field failure. Field downtime cost of equipment, like X-ray or heart scanning and monitoring devices, can be extremely expensive. Plus, there are liabilities associated with that downtime, thus proving costly to both the OEM and its healthcare customers.

To minimize those issues, it’s a good idea to apply in-circuit test (ICT) to mature medical electronics boards. ICT sends a signal through the board to ensure all active components are properly working. If there are component failures, they are flagged, and re-tested. Thus, ICT acts as an insurance policy for accurately making medical devices.

After ICT, functional testing may be mandatory for a given medical electronics products. Here, it’s important to test the design on the bench and in the lab before it goes for mass production. Over time, the board is exposed to a battery of tests. If a board is undergoing R&D, it should be run through different humidity and temperature cycles, as well as a different battery of tests to assure a robust product build.

Fabrication

There are no shortcuts associated with medical PCB fabrication. Quality is of utmost importance for medical electronics products. For both the OEM and CM, this means fab-shop selection calls for ISO and/or mil spec certification. More often than not, it is best to process medical electronics boards using mil spec certification. The reason is, mil spec is a slightly higher certification compared to those for medical electronics. Thus, the reasoning is it’s better to go above and beyond to assure higher quality and reliability of medical products.

Also, it’s a good idea to maintain an incoming quality control (QC) process at the beginning stage when fabricated boards arrive at the CM’s dock. QC should include checking for multiple board aspects, such as hole tolerances, cutout verifications, board dimensions, and surface finishes. In regard to finishes, the CM should be well aware of the various trade-offs and characteristics associated with HASL, ENIG, and OSP to avoid mistakes at assembly. QC should also include reviewing test coupons, board cross-sections, TDR reports, and material certification before boards are released to the floor for assembly.

Correct impedance control calculations must be carefully implemented at fabrication to obtain desired results. Otherwise, unwanted signal noise leads to erroneous results in a medical electronics system.

Moreover, there are proper procedures and processes at the fabrication level that must be strictly followed. Proper baking cycles must be performed with no shortcuts taken. Special consideration needs to be given when mixed materials are used. For instance, careful thought must go toward mixing FR4 and Rogers layers because issues could arise when these materials are laminated together due to the different temperatures profiles for lamination cycles.

Assembly

When it comes to assembly, quality, and repeatability, reliability plays an especially important role. Like mentioned above for fabrication, similarly, there are no shortcuts for successful assembly of medical electronics devices. The thermal profile is crucial, especially if the product is lead-free. Increasingly, with the EU and China’s RoHS exemptions coming to an end for medical products, OEMs have been transitioning to lead-free during the past few years. But certain precautions still dominate assembly. A particular profile must be correctly designed and implemented for a given medical electronics PCB. One size does not fit all, and all thermal profiles aren’t created equal. Further, the CM or EMS provider must exercise special expertise when hybrid products containing leaded and lead-free components are subjected to re-flow. If care is not applied, an entire PCB project can be damaged and those boards must be scraped.

Properly defining a stencil design and solder paste dispensing are equally as important as a correct profile. If the right paste, stencil, and correct profile are used, then about three quarters of potential issues at the re-work and touch-up rework phases are eliminated.

Fig 4 Operator inspecting a medical device using an x-ray machine

In addition, an assortment of advanced systems and equipment assure quality and reliability. Automated optical inspection (AOI) is used to make sure of consistency; X-rays provide assurances all joints are proper (Figure 4); first article inspection (FAI) makes inspection and QC more reliable, repeatable, and faster. The more use of automation, the less human intervention is required, thus eliminating human error.

Lastly, an experienced CM should always maintain a constant check on its assembly processes and procedures. The idea is to sustain assembly strengths at the highest levels possible to efficiently produce quality medical products. Plus, those processes are made repeatable with minimal effort so that at QC stages, there are no surprises.

ISO 13485 Puts It All Together

ISO 13485 places considerable emphasis on risk management activities or design transfer activities during and after a medical product development cycle. That alone differentiates it from less stringent and demanding ISO standards relating to commercial applications.

Medical product risk management is categorized in a couple of ways. First, it deals with identification, assessment, and prioritization of risk that could be associated with these specific products. Secondly, coordinated and economic resources are applied to minimize, monitor, and control the impact of unfortunate events that might otherwise occur if procedures aren’t put in place and exercised.

The standard deals with five specific aspects when a medical product is designed and assembled:

• Identifies, characterizes, and assesses impending damaging threats.
• Assesses vulnerability of assets based on identified threats.
• Determines the amount of incurred risk.
• Identifies ways to reduce risk.
• Prioritizes risk reduction based on specific strategies.

ISO 13485 requires a large amount of traceability in terms of medical products, and PCBs must be serialized and allocated in terms of batches, which means that these products can be traced from lot and batch codes. Further emphasis is placed on component traceability. If a component or set of components encounter a problem or slightest issue at PCB design or assembly stage, or even in the field, then there must exist a formal, well-documented paper trail leading back to suppliers and manufacturers associated with those component lots.

Moreover, the standard calls for specific requirements dealing with inspection documentation, process validation for sterile medical devices, and verification of the effectiveness of preventative and corrective actions. ISO 13485 also determines the sequence and interaction of processes involving medical product design and assembly. For each medical device model, an EMS provider, CM, or OEM organization is expected to maintain a file either containing or identifying all documents that define product specifications and quality management system requirements.

Documents like these define the complete manufacturing processes. If applicable, medical device installation and servicing processes are included as well. In effect, ISO 13485 establishes a documented procedure for a feedback system that provides early warnings of quality problems and input into corrective and preventive actions before subjecting a medical product or PCB to production.