Exploring Systems EMC in Medical Devices

With many devices, particularly small ones, the design approach is straightforward, using basic EMC design practices including shielding and filtering. But with more complex equipment, it may not be possible to protect the entire system, for one reason or another. For example, operator access may be needed during operation. Diagnostic equipment, injection systems, interventional lasers, and other devices may incorporate electric motors, lasers, high-power lamps, and power hardware for their functions.

Achieving EMC with complex systems may be not be easy, but following some basic guidelines at the front end of the design cycle eliminates many problems and minimizes the effect of those inevitable gremlins that show up downstream. The use of modest EMI (electromagnetic interference) control techniques throughout the system minimizes the need to take extraordinary steps at the last minute.

This article outlines the basic steps of systems EMC design for medical devices, but first some preliminary thoughts.

EMC is pretty well covered by the regulatory requirements specified in IEC 60601, with modifications for special cases—technology always stays a step ahead of the regulators. Compliance with this standard is mandatory in much of the world, including the United States and Europe; most countries enforce it vigorously.

The standard covers both immunity to external interference and emissions from within the equipment, but the primary emphasis is on immunity, as it affects patient safety. Immunity requirements include external radiated electric and magnetic fields, conducted radio-frequency (RF) interference (RFI) and various power disturbances, and electrostatic discharge. (By the way, the term susceptibility is used instead of immunity in the military and automotive worlds—they are referring to the same issue.) The emission requirements limit energy emanating from the equipment to minimize interference to nearby electronic equipment, notably radio receiving equipment. This is usually not a safety issue, but there are exceptions.

The goal for all of the requirements is to ensure that the device will operate satisfactorily in its intended environment and degrade gracefully when the electromagnetic environment is worse than projected.

Grounding and shielding form the core of EMC systems design.

Grounding. The key issue in grounding is the impedance in the ground (or return path). Any time two or more circuits share a ground path, they also share voltage drop along the common path. The voltage generated by one circuit appears to the other circuit as an undesired signal. This is true wherever signal or ground currents flow, whether on the circuit board, interconnect cables, enclosure members, etc. Figure 1 shows the effect of ground impedance.

Single-point grounds are often cited as a solution to electromagnetic interference (EMI) problems, and they are very effective for controlling audio frequency noise. In Figure 1, the ground is broken at the “X” and moved to a single point, as indicated by the dashed line. However, single-point grounds are often not feasible. Worse, they don’t work at higher frequencies—path inductance and standing waves cause voltage drops along the way, and stray capacitance creates stray alternate paths. In these cases, the designer should look for low-impedance ground paths as the preferred way to control EMI.

The bottom line is, ground everything as often as possible. Don’t worry about ground loops. Once there is more than one ground, there is a multiple-point ground, and the only solution is to make impedance as low as possible. This task is best accomplished by using wide structural metal members, preferably sheet metal, and bolting them together at frequent intervals. If a metal chassis is not available, the only alternative is to ground through the cables, which is not a palatable choice—ground straps and wires are too inductive to be effective above audio frequencies.

Mating surfaces must be conductive and provided with a good contact area. Specifically, screw threads, hinges, latches, and bearings are unacceptable as ground connections.

In sum, multipoint grounds are needed for high frequencies and single-point grounds (or no grounds) are more appropriate for low-frequency analog circuits and motors.

Shielding. Figure 2 boils EMC shielding down to its basics. Any electronic device is at risk to external radiated interference, which can be contained through the use of a metallic shield. For the most part, this shield will contain radiated emissions from the device as well. The interference that enters or leaves the enclosure by conduction, through either the power or signal lines, need to be blocked by cable shielding or filtering. Thus, if a satisfactory shield can be implemented that either filters or shields the cables, this setup offers a solution to the regulatory issue. Of course the equipment still has to withstand internally generated interference.

Complete coverage of shielding and filtering would take up an entire book (and there are several good books available) and is beyond the scope of this article. However, a brief summary of the concepts is warranted because they are integral to the systems approach. Good shielding requires nearly complete closure—openings and seams must be minimized. In the authors’ experience, a good guideline to follow is that the longest dimension of the opening must be less than 1/20 of the wavelength of the highest threat frequency.

L = λ/20, where L is longest dimension of the opening and λ is wavelength, given by:

λ = 300/f. λ is measured in meters, f is in MHz.

The highest threat frequency will usually be the maximum RF immunity and emissions test frequency, usually 1 GHz. As an example, if there is a maximum threat frequency of 1 GHz, λ is 1/3 of a meter and maximum L = 1.5 cm. Of course, if the module can’t respond to a frequency that high, the closure requirements can be relaxed a bit.

Shielding can be achieved with any reasonably conductive material. Similarly, thickness of the material is also of little consequence—conductive coatings provide ample high-frequency shielding effectiveness. In almost all cases, the limitation is the openings; closing the seams will be the driving factor. The exception is shielding for low-frequency magnetic fields, especially 50–60 Hz, in which case thick, permeable materials are needed.

Wires penetrating the shield need to be shielded or filtered, depending on the application. As a rule, power lines and low-frequency signal lines are filtered and high-speed signal lines are shielded. In particular, patient-connected signal lines are essentially impossible to shield fully because the patient ends need to be exposed. The authors avoid transient suppressers, but they may be considered where permitted.

Now that we have the basic shield in mind, note that the designer is free to select the shield boundaries, as long as those boundaries enclose the elements of interest, i.e., keep offending energy inside the shield and external energy outside of the shield. In the extreme case, there might be a single chip that is vulnerable to external radiated interference. Only the chip would need to be shielded, but there would still be concern about energy conducting into the pins. Or if the entire circuit board is a potential problem, some might shield the entire circuit board. Television works on this principle—the only circuit shielded is the TV tuner. Or, if we have a number of circuit boards, a shield might be used around the card cage.

But designers are not constrained to using a single shield; they can use as many as needed, as long as the shielding rules are followed for each module, and the wires penetrating the shield are either filtered or shielded. Figure 3 shows the principle: the shields have been moved inside to protect the critical areas, and shielded and filtered cables have been installed as needed to provide system protection.

Now that the basic grounding and shielding concepts are in mind, let’s turn to the initial design. The military world takes EMC seriously, usually requiring an EMI control plan (see DI-EMCS-80199B) to be prepared and submitted for review. Medical device manufacturers may not want to do this formally, but they should take the appropriate steps early in the design phase. The sooner EMI issues are addressed, the more design options there are. Consider the steps that follow.

If a manufacturer’s only concern is the regulatory issues (usually IEC 60601-1-2) and its equipment is covered by the requirements, this step is easy—all the thinking has been done for the company. But it is still appropriate to think beyond the regulations, by asking the following questions: What is the consequence of failure? Must the device be fully operable 100% of the time, or can it tolerate brief interruptions and, if so, for how long? These questions are pretty well covered by IEC 60601, but do perform a sanity check.

Is the equipment to be placed in an environment not adequately covered by IEC 60601? If it is to be operated in a vehicle, such as an emergency vehicle or aircraft, then the manufacturer might have to go beyond the regulations.Are there any internal components that are especially noisy or sensitive? Here, the designer needs to consider not only the regulatory issues, but also the internal self-compatibility issues. Here are some quick guidelines.

Interference Sources. Continuous emitters include all clocks and associated data buses, switching power supplies and regulators, pulse-width modulation motor drives, electric motors, RF heaters, fluorescent lamps, and others. For the most part, these elements are generally only an issue with regards to emission limits, but RF heaters and diathermy may be energetic enough to create an internal interference situation.

Transient noise sources mostly originate from switching heavy loads, usually inductive loads such as motors and transformers. Starting loads tend to cause power sags and stopping loads tend to cause voltage spikes.Interference Receptors. Although all electronics can be affected, given enough source energy, the authors find that analog input devices are much more vulnerable to RFI and digital devices are more vulnerable to transient events. Power electronics and electromechanical devices are usually the least vulnerable. But do note that the feedback path in voltage regulators are sensitive analog devices, and they are very sensitive to RFI. Even power and electrostatic discharge (ESD) transients can create a brief power sag, resulting in digital upset.

Most often, internal electrical or electronic modules are a subassembly, which might include a power supply, a microprocessor-based controller, patient connections, motors, actuators, and display and operator controls. Occasionally, it is feasible to combine two assemblies into one boundary, for example, the display and touch pad.This setup is going to be just a part of the system design, as the location of these elements is probably going to be driven by considerations other than EMI. But where there are internal threats, EMI will have to be given its share of attention. As an example, physical separation of noisy sources and sensitive receptors is one of the best options—keep them as far apart as is feasible, including cables.

Once the designer has decided on the key threats, the next step is deciding where to put the protection. Which modules need to be shielded, and which cables need to be filtered or shielded? Is the existing housing adequate or does it need to be shored up? If there are internal threats, potentially fighting with each other, then internal protection is needed. If all threats are external (either emissions or immunity), the protection boundaries can be placed where appropriate, as long as the protection lies between the affected circuits and the outside world. Where shielded cables are used, the shield must be circumferentially clamped to the connector shell and grounded at both ends.

Electromechanical devices such as ac or dc motors generally don’t need shielding, but may well require power filtering. Most electromechanical devices involve switching a substantial inductive load, so switching transients need to be contained, preferably as close to the load as possible. Usually, this containment is achieved by use of a resistor-capacitor filter or perhaps a diode snubber. Also note that motor drives (e.g., pulse-width modulation or variable frequency drivers) output substantial amounts of RF energy that will need to be contained, and power-cable shielding may well be a satisfactory choice for containment.

Microprocessor modules are the principal emitters, and they may also be vulnerable to RFI. These modules must be properly shielded. High-speed data cables often need to be shielded as well because filtering is usually not an option. Power-feed and low-frequency signals are generally filtered.

Visual displays are rarely shielded because shielding can degrade the image quality and brightness. Generally, the shield is placed behind the display, and the bezel is grounded at the perimeter to minimize antenna effects. Touch pads and operator controls need to be protected from ESD.

Patient isolation is one of the difficult areas. Full cable shielding is not feasible, and filtering is decidedly restricted—capacitance to enclosure ground is sharply limited. Basically, all protection needs to be referenced to the isolated area.

Designing the enclosure requires the following.

Design the Ground. This can’t be emphasized enough. Designers can use as much metal as they want (see Figure 4), but make sure that all the members follow the 5:1 rule mentioned previously, and that the mating surfaces are continuous or nearly continuous. Ideally, joints are welded or, as a second choice, secured with lots of screw fasteners.

Position the Modules Sensibly. Modules that interface with the outside world should be close to the enclosure boundary. Bolt all modules directly to ground. This guideline covers the module housing; the contents may be isolated from ground.

Ensure Low Impedance for Mating Surfaces. First, the mating surfaces need to be conductive. Painted surfaces and anodizing need to be masked at the mating surfaces. Conversion coatings can be used, but they need extra mating-surface area. Screw threads, hinges, latches, and shudder bearings are not satisfactory for low contact resistance. If these must be used, provide a ground strap to go around.

Such a setup poses a problem when mounting electronics on the door panel—there needs to be a good ground connection between the housing and the access door. At a minimum, route a ground strap between the housing and the door as well as running interconnections alongside the ground strap. Or better yet, run the cables through a cable shield and ground the cable shield at both ends.

Once the ground is in place and the modules are bolted to the ground, the cables need to be routed. First and foremost, put the cables under control drawing. Internal cables should be routed adjacent to ground to minimize loop areas and, hence, antenna effects. Space the cables to minimize crosstalk between high-energy cables near sensitive receiving circuits. Where they must cross, make a perpendicular crossing.

Metal housings (motors, power supplies, card cages, etc.) need to be grounded to each other and to the ground system previously described. Floating or poorly grounded metallic members do no good and may even cause problems.

Waiting until the last minute to get test data guarantees schedule slippage and cost overruns. Get preliminary test data as early as possible so that corrective action can be taken early in the game. Everything doesn’t have to be working in order to obtain useful test information—you don’t need to do full testing, and the test need not be highly calibrated. The sooner the testing is done, the more options there are for fixing problems.

EMC requires planning and it won’t happen by accident. Follow the military guidelines for planning and executing an EMC program, at least informally. Don’t use the excuse that there isn’t time. As one of Murphy’s laws says, “There is never time to do it right, but there is always time to do it over.”

Most EMC problems are identifiable. With a little planning, major problems and many minor problems can be avoided. Most notably, low impedance grounding is mandatory. There will always be something you missed, but if you have done your homework, the problem should be fixable without major redesign.

DI-EMCS-80199B, “Electromagnetic Interference Control Procedures (EMCP),” 1990.

IEC 60601-1-2, “Medical Electrical Equipment—Part 1–2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests” (Brussels: International Electrotechnical Commission, 2005). 

William D. Kimmel, PE, and Daryl D. Gerke, PE, are partners in Kimmel Gerke Associates Ltd. (South St. Paul, MN, and Mesa, AZ).

EU Draft Regulations Are A Nightmare For Intellectual Property—And Innovation

Proposed EU regulations are causing major headaches for patent holders.

The EU has formulated some frankly alarming draft regulations about standard essential patents (SEPs) that will affect many tech companies, large and small. Among other things, the new rules would give the EU Intellectual Property Office the authority to set what it considers fair royalty rates for these fundamental technologies, rather than leaving that to the market. I’m adding this top-down rate-setting scheme to my list of Very Bad Ideas from Regulators, right next to the ill-founded opposition to the Broadcom-VMware and Adobe-Figma deals.

Based on conversations with IP experts and my own research, these regulations seem certain to do a lot of harm, which isn’t a surprise when you assign bureaucrats to set prices. I have no idea why the EU thinks that agency officials with no experience in operating a business, let alone negotiating SEP deals, will be able to administer prices for patents that affect everything from cellular telephony to semiconductors, but that’s what they’re proposing to do.

Unsurprisingly, the draft regs have drawn vigorous responses from various quarters, starting with big patent holders like Qualcomm (who practically wrote the book on IP licensing) and Nokia. Joining the chorus are U.S. Senator Chris Coons, who chairs the relevant subcommittee of the Senate Judiciary Committee, and U.S. Secretary of Commerce Gina Raimondo, both of whom are rightly concerned about how this would damage the competitiveness of U.S. and European firms—to the benefit of China.

There’s still a little time to get it right, but the EU needs to use the current comment period to listen to all the relevant stakeholders, climb down from what right now is a flatly unreasonable approach to SEPs and find a new path forward.

Why SEPs matter so much

As the name implies, SEPs are essential chunks of IP used in technology development, for example in 5G networks. So whatever the EU decides about how it handles SEPs will carry enormous implications for both the organizations that develop fundamental IP (the inventors) and the companies that put those innovations to use (the implementers). If we stick with the mobile connectivity example, the inventors include companies like Qualcomm, Nokia and Ericsson, while the implementers include both smartphone makers—with Apple at the head of the list—and other manufacturers such as automakers.

SEPs are a notoriously complex area of IP, which is reflected in the EU’s own recently-published report about the challenges involved in SEP licensing. That long, detailed study was written by a panel of European and U.S. experts on IP and covers many associated topics in depth. The corresponding regulations benefited from a couple of years’ worth of meetings that took input from the various stakeholders in the industry.

One of the good things to emerge from that collective effort is a new user-friendly database that clarifies exactly which inventors hold which patents. This is a laudable effort that helps implementers, including smaller ones like auto parts suppliers, to find out which IP they will need to license for a specific device and which company they will need to license it from. Both inventors and implementers contributed to the project, and ultimately all parties will benefit from having this new database.

Unfortunately, that collaborative working environment came under immense scrutiny at the end of April when the EU changed its tune abruptly. All the complexity and nuance of SEPs, plus the years of cooperative input from everyone, didn’t stop the EU commissioner responsible for IP, Thierry Breton, from coming out with guns blazing against the inventors when he announced the draft regulations. Without naming names, he accused at least some of the patent-generating companies of acting in “bad faith” and operating as “de facto monopolies”—which he intends to “bust.”

The EU tries to regulate SEPs far beyond Europe

The sudden shift in tone obviously isn’t a great way to make friends. Neither is the EU’s assertion of its authority to unilaterally set a fair, reasonable and nondiscriminatory (FRAND) price for each patent that comes under its jurisdiction. As a practical matter, SEP license agreements are negotiated between companies on a global basis. So, for example, if Apple needs to incorporate some of Qualcomm’s IP into a new iPhone model, the two companies sit down, work out a price that’s in line with the market rate and then go on about their business. Sure, there are lots of factors that come into play, and of course there are various legal avenues to pursue if someone believes they’re being cheated. Indeed, observers of this industry will immediately recall that Qualcomm did exactly that when it sued Apple across multiple jurisdictions for misusing its IP. (Apple initiated the legal spat and ultimately settled for a large sum.) But fundamentally it’s a market-driven transaction.

With the proposed new regulations, however, the EU looks like it’s engaged in a power grab to become not just Europe’s but the world’s central rulemaking authority for SEPs, specifically because it wants to set the single most important term of any deal: the price. It wants to do that by setting royalty rates for patents. Then it wants to determine who’s being a good actor or a bad actor—and “bust” the bad ones. And it wants the whole world to fall in line with whatever it decides.

Set aside for a moment the patent holders who stand to be unfairly harmed by the regulations. It’s no wonder that lawmakers in the U.S., the U.K. and other jurisdictions are likewise up in arms.

Likely impacts if the EU regulations go ahead

Another complaint from the inventor side is that the regulations don’t address the issue of “hold-out,” which happens when an implementer uses IP but withholds payment for it. This practice favors implementers because it allows them to delay payment, sometimes to the point that they can force the patent holder to accept a lower price than it otherwise would have.

Hold-out has been a significant thorn in the side of SEP holders for years, but Breton’s comments when the draft regulations were announced didn’t address it. Nor did he extend his criticism to implementers in any other ways, which only reinforced the message that he sees patent holders as bad actors in the SEP arena. So it makes sense to extrapolate that Apple, the automakers and other implementers would benefit from the proposed new regulatory regime.

Meanwhile, there are plenty of downsides to go around for everyone else. Categorically, the new regs are too invasive in terms of price-setting, and both Breton’s statements and the wording of the regulations themselves make it clear that patent holders will be on the firing line. I’ve also seen analyses from longtime IP watchers who believe that the new rules probably won't even reduce litigation. On top of that, I understand that one of the judges for the EU’s brand-new Unified Patent Court (UPC)—which only began to operate on June 1—has criticized the proposed regulation for effectively taking a key point of jurisdiction away from the UPC even before the court has gotten off the ground.

In the bigger picture, Senator Coons, Secretary Raimondo and their counterparts in the U.K. and elsewhere are right to worry about sustaining the competitiveness of tech-driven businesses in their countries. To be clear, those who are concerned about this include many business leaders within the EU itself who see the writing on the wall for what slow, non-market-driven price-setting, not to mention the regulations’ other shortcomings, would do to weaken the environment for technological innovation there.

Building great technology is hard enough when regulatory regimes are streamlined and compliance costs are low. Commissioner Breton has said some nice things about encouraging patent-protected innovation, but I don’t think he registers just how chilling it will be if these regulations go into effect. Why would people want to risk their capital to start a company and invent a groundbreaking product if they can’t set a fair market price on that product? Far from fostering the kind of environment where innovation can thrive, these rules will inject higher transaction costs (more lawyers etc.) and more uncertainty into doing business in the EU.

You have to think that’s an unintended consequence of the new regs. But being unintended will be little consolation when the rules work to undercut the innovation, especially among SMEs, that the EU says it wants to promote.

For the parts that ain’t broke — don’t fix them

That study on the challenges involved in SEP licensing that I mentioned earlier? It concluded, in a nutshell, that those challenges were not severe enough to discourage either inventors or implementers from participating in the current system. So why the sudden push to completely reframe the way SEPs and FRAND determinations are handled?

Not to be hyperbolic, but centralized price-setting died out in Europe with the collapse of the Soviet Union—and good riddance. Nobody needs a top-down, government-driven rate-setting scheme, especially when the current system has worked for decades. Seriously- has price setting ever done well for any country long-term?

Improvements like the new transparency database and the creation of the UPC are welcome, because they stand to make the whole system run smoother. But if a major revision to the fundamental rules of engagement was in order, the best time to handle that would have been during the drafting phase, when all the relevant parties could engage in constructive dialogue.

Next steps for SEP holders

Qualcomm is Exhibit A of a company that has used patent R&D and licensing to drive innovation while building a great, durable business. I had the chance to get a refresher on the Qualcomm business model with some of its leadership team a few months ago, and it’s clear to me that their approach to licensing sets the industry standard. They’ve also worked hard to support a collaborative process for the new EU regulations, and from talking with them more recently I can tell they’re as stymied as I am by the direction that the EU has now taken.

You can bet that the EU regs will be top-of-mind for the IP experts gathered at the IPBC Global 2023 conference in San Diego that starts on June 12. Two senior executives for Qualcomm, John Han and Bob Giles, will be speakers at the event. (Han is general manager of Qualcomm Technology Licensing, while Giles is Qualcomm’s chief IP counsel.) I’m going to follow up after the event with them and other attendees to find out what’s the latest thinking on these EU regulations from the IP experts who deal with these issues in the real world.

Meanwhile, I’m frustrated to see another installment in the recent sequence of regulators who seem to lack an understanding of how business genuinely works, what motivates people, how markets are created and how they die. Why would any company invest tons of money, ever, in SEP-creating research for market-forces to be cast aside and set by bureaucrats who have never run a business themselves?

I hope that the EU regulators will do the right thing with SEPs—or maybe it will come down to members of the European Parliament who are motivated to get to the bottom of the issue. One way or another, what we need is a balance between the companies that invent technology and the companies that implement it into their products.

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