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The Importance of ANSI C63.27 in Wireless Coexistence Testing for
Connected Medical Devices
PLUS
Increasing Correlation of Testing of Battery and Fuel Cell Powered Systems With Their Real-World Applications

Complying With the EU’s EMC Directive Without 3rd Party Testing

Methods and Effects of Magnetic Pulses on the Magnetoreception of Birds

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PLUS
Increasing Correlation of Testing of Battery and Fuel Cell Powered Systems With Their Real-World Applications

Complying With the EU’s EMC Directive Without 3rd Party Testing

Methods and Effects of Magnetic Pulses on the Magnetoreception of Birds

April 2024
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EMC Concepts Explained
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On Your Mark
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Hot Topics in ESD
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Troubleshooting EMI Like a Pro
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April 2024
Volume 16 l Number 4
Contents
By David Schaefer
Integrating a radio into a medical device can have many benefits but also introduces new challenges in compliance. Ensuring coexistence with other radios can be critical to the essential performance of medical equipment.
By Nicholas Ingarra and Mark Steffk
The exponential increase in the demand for battery and fuel cell powered systems has resulted in challenges regarding the development of effective and efficient test procedures that can also increase their correlation to those systems’ real-world performance. By using the principles of the physics of energy storage and transfer, various analysis techniques (both traditional and computer-aided) can help engineers meet those challenges.
By Keith Armstrong
Many manufacturers believe that 3rd party testing is required for meeting the requirements of the EU’s EMC Directive. But there are other, legally-acceptable paths to demonstrate compliance with the EMC Directive that do not require the use of a 3rd party.
By Jose Martin Hernandez Pina and Jeremiah Szanto
This article examines various hypotheses regarding avian magnetoreception and discusses experimental techniques to investigate potential sensory mechanisms for bird navigation.
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digital battery
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Ask the Expert
Medical
compliance news
FDA Warns Manufacturers to Scrutinize Third-Party Testing Data
The U.S. Food and Drug Administration (FDA) is reminding medical device manufacturers to independently verify testing results generated by third parties that are included in premarket submissions to the agency.

In a Letter to Industry, the FDA notes that it has observed an increase in recent years of contracted third-party testing laboratories fabricating test data, duplicating test data used in other device submissions, or providing unreliable characterizations of their testing. Although the Letter does not identify specific testing laboratories that have generated fabricated test data, it does point to…

FCC Makes AI-Generated Robocalls Illegal
In a landmark decision, the U.S. Federal Communications Commission (FCC) has unanimously ruled that robocalls made with voices generated by artificial intelligence (AI) tools are illegal.

In a Declaratory Ruling issued in early February, the Commission summarized its determination that calls that include AI-generated voices are “artificial” under the Telephone Consumer Protection Act (TCPA) and, therefore, illegal. Under the TCPA, violators are subject to FCC enforcement authority, including fines and actions to block calls from telephone carriers that facilitate illegal robocalls. In addition…

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Feature Article
The Importance of ANSI C63.27 in Wireless Coexistence Testing For Connected Medical Devices
Understanding How Radios Affect Medical Device Compliance
By David Schaefer
researcher looking at tablet with x-rays in the background
C

ommunication has advanced at an unbelievable pace in the 150 years between the Pony Express and the advent of the internet. The shelf life of information has drastically decreased, from weeks to seconds, and the distance we are willing to travel for information has shrunk to virtually nothing. We demand instantaneous access to a massive range of data, no matter where we may be in the world. Companies are spending billions of dollars for faster access to information, and consumers spend more each year on faster devices. Cellular carriers, aware of this trend, have shifted from voice-only networks to data-centric services and are relying more heavily on spectrum sharing.

The first recognizable iteration of Wi-Fi launched in 1999. Prior to 2008, about two billion Bluetooth devices had been sold. But, in 2022 alone, 4.9 billion Bluetooth devices were shipped in the span of a single year. There are now Wi-Fi access points in planes, dog collars with GPS, and toothbrushes with Bluetooth connectivity. Radio devices are everywhere, and there are more users, more devices, and greater saturation of frequency bands.

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Ask the Expert
Every company has a story. Get to know some of the most influential compliance partners in the medical electronics industry.
a special sponsored section
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ETS-Lindgren equipment
ETS-Lindgren
1301 Arrow Point Drive, Cedar Park, TX
(512) 531-6400 | https://www.ets-lindgren.com
ETS-Lindgren equipment
ETS-Lindgren is a multinational organization established with the goal of developing testing environments that enhance human intelligence and improve lives. We empower our customers to meet compliance requirements effectively while manufacturing next-generation products that advance human intelligence, improve medical outcomes, and enhance lives.
Our Legacy
Rooted in the legacy of Ray Proof from the 1930s, ETS-Lindgren has been serving the RF Shielding and Test and Measurement needs of our customers for nearly a century. Our commitment to innovation remains steadfast as we continuously evolve to address the changing needs of our customers. From electromagnetic pulse (EMP) solutions safeguarding critical infrastructure to MRI shielding systems facilitating life-saving patient imaging, and from electromagnetic compatibility (EMC) test solutions enabling the delivery of cutting-edge consumer, medical, and automotive products to market, to wireless test systems driving the development of the latest wireless technology, ETS‑Lindgren empowers our customers’ success through an extensive product and solutions portfolio and access to our knowledgeable industry experts.
What Sets Us Apart
What distinguishes us goes beyond our products and solutions; it’s our ability to collaborate with our customers to solve their challenges. Working closely with our customers, our experts have developed tailored test solutions to streamline testing processes, designed hydrogen gas management systems as part of EMC testing solutions for vehicle hydrogen fuel cell testing, and created a vehicle antenna measurement arc (VAMA) to efficiently characterize and test the various antennas on the next generation of vehicles. These are just a few examples of how ETS‑Lindgren supports our customers’ objectives.

At ETS-Lindgren, customer-centricity is paramount. We approach every customer request by listening attentively, understanding their needs and challenges, and working collaboratively to identify effective solutions.

Moreover, we remain committed to supporting our customers beyond solution delivery, providing ongoing product maintenance to prolong solution life and effectiveness, personnel training to optimize productivity, and upgrades to enhance solution utility.

Behind the Innovations
We take immense pride in supporting both our customers and the industries we serve. Our experts actively participate in various standards bodies and engineering organizations, including CISPR, ANSI, ISO, 3GPP, ETSI, IEEE, AMTA, EuCAP, and APEMC, among others, disseminating knowledge through papers, tutorials, workshops, and active involvement in groups and events such as IEEE’s Women In Engineering and Young Professionals. At ETS-Lindgren, our commitment to the industries we serve is not just a statement but an integral part of our culture, evident through our actions.

At ETS-Lindgren, we are Committed to a Smarter, More Connected Future.

TÜV Rheinland North America
400 Beaver Brook Road, Boxborough, MA
(978) 266-9500 | https://www.tuv.com/us/en
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Jessamyn Duterte | jduterte@us.tuv.com
Technical Manager, Medical Testing
Our Heritage
TÜV Rheinland’s heritage is rooted in ensuring technology benefits humanity, a principle upheld since its founding on October 31, 1872. Initially focused on steam boiler safety, the organization evolved into the Technical Monitoring Association (TÜV), now a global testing leader with over 20,000 employees and labs worldwide. Recently, we opened a state-of-the-art lab in the Greater Boston area and expanded accreditations at our Pleasanton, CA facility. This growth reflects our ongoing dedication to advancing safety, quality, and environmental stewardship through innovative testing services.
Our Services
Leveraging our 80+ years of medical product safety expertise, TÜV Rheinland offers comprehensive testing services spanning wearables, handheld devices, and proton beam therapy centers. Setting us apart is our extensive service range and unwavering customer focus, including preliminary compliance reviews, design assessments, and engaging Lunch and Learn Events.
Why Customers Choose TÜV Rheinland
Our globally experienced team certifies medical devices to international standards. We prioritize clear communication and customer support, offering tailored solutions and prompt resolutions to challenges encountered during the certification process. While clients are initially drawn to our comprehensive testing capabilities, it’s our exceptional customer service and technical proficiency that fosters enduring partnerships.
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Feature Article
Increasing Correlation of Testing of Battery and Fuel Cell Powered Systems with Their Real-World Applications
Using Established Circuit Analysis Techniques and New Capabilities in Modeling/Simulation Tools Can Improve the Understanding Of Battery and Fuel Cell Powered System Performance
By Nicholas Ingarra and Mark Steffka
digital graphic of a battery in blue
T

oday’s communication, transportation, and power delivery systems all depend on the extensive use of batteries to keep them functioning in a safe and reliable manner. Battery cell technology has its origins in the late 1700s, while fuel cells were not available commercially until the mid‑20th century. But today’s batteries and fuel cells are an amazing combination of the application of principles of chemistry and electrical engineering.

The standard approach today is that when a battery is the only power source of an electrical system (referred to as the primary power source), analysis techniques are normally applied to characterize the battery as being able to supply constant input voltage to its load. As we have all experienced in our daily lives, constant input voltage conditions do not really exist unless there is an additional power source to maintain the battery’s state of charge.

Feature Article
Complying With the EU’s EMC Directive Without 3RD Party Testing
By Keith Armstrong
hand typing on laptop keyboard next to a blue spiral notebook with a yellow lock circled by yellow stars design
A

common path to achieving compliance to the European Union’s (EU’s) EMC Directive 2014/30/EU (which I shall call the EMCD here) takes many manufacturers down the route of utilizing a third-party EMC test laboratory to obtain EMC test reports for their products. This process was detailed in the article “IT Server Hardware Compliance, Part 1,” which appeared in the December 2023 issue of In Compliance Magazine [1].

However, it is important to understand that the EMCD contains no legal requirements for performing any EMC laboratory tests. This was equally true for the original EMCD, 89/336/EEC, and its 2nd Edition, 2004/108/EC.

Feature Article
Methods and Effects of Magnetic Pulses on the Magnetoreception of Birds
Exploring Magnetic Sensing Mechanisms in Avian Navigation
By Jose Martin Hernandez Pina and Jeremiah Szanto
birds flying during sunset
T

he Earth’s magnetic field is a dipole that acts like a large magnet, with its poles relatively near to the geographic (rotational) poles. Although the magnetic north pole is really in the geographic south position and vice versa, the magnetic north pole is typically referred to as the end of the dipole closest to the geographic north pole, and the magnetic south pole is similarly referred to as the end of the dipole closest to the geographic south pole. The geomagnetic field lines of force leave the magnetic South through Antarctica, circle the Earth, and re‑enter through the magnetic North’s surface, through the Arctic pole, creating vectors of these ascending lines of force in the Southern Hemisphere and descending lines of force in the Northern Hemisphere, which are parallel to the earth’s surface at the equator.

As one moves closer to the equator, the strength of the lines of force steadily declines, reaching maximum values of around 60,000 nT at the poles and around 30,000 nT at the Equator [1]. These characteristics make the magnetic field a very reliable and omnipresent source of information, in which the magnetic vector (the vector between the line of force of the magnetic field and the line of force of gravity) provides directional information that the bird can use as a “compass.” Further, the spatial distribution of other factors, such as intensity or inclination, can be components of the “map,” providing information on the geographic position of the bird as they vary between the poles and the equator. [2, 3].

EMC concepts explained
Impact of Decoupling Capacitors and Trace Length on Conducted Emissions in a CMOS Inverter Circuit
By Bogdan Adamczyk and Mathew Yerian-French
T

he impact of decoupling capacitors and a PCB trace length on signal integrity was discussed in [1], while the impact on radiated emissions was discussed in [2]. In this article, we evaluate the impact of the capacitors and trace length on conducted emissions.

1. CMOS Inverter Circuit
Figure 1 shows the block diagram of the inverter circuit and the PCB. In this study, trace length varied between 3,000 mils (short trace) and 20,000 mils (long trace). Additionally, the PCB was tested in two configurations: without the decoupling capacitors and with decoupling capacitors by each inverter (0.1 µF and 1 µF).
hot topics in ESD
The ESD Association Technology Roadmap
By Mirko Scholz for EOS/ESD Association, Inc.
T

he ESDA technology roadmap is written to support and guide the daily work of ESD and latch-up experts in the worldwide industry and academia. At the same time, it is intended to provide a glimpse into the future ESD thresholds of semiconductor devices and their impact on ESD control practices. It also presents current and future technical challenges in ESD and latch-up. With their expertise vision, the ESDA Advanced Topics Team has completed the most recent edition, published in January 2024 [1]. In this article, we want to highlight some of the changes and look at one key trend in advanced packaging.

ESD Target Level
The evolution of Charge Device Model (CDM) target levels was previously summarized in [2]. As technologies further advanced, it became necessary to reduce CDM target levels from 500 V to 125 V for ultra high-speed IO applications. However, depending on the IC design functions, the achievable level can be 500-125V. Looking forward to the next decade and beyond this can be even below 125 V. Figure 1 shows the device ESD design sensitivity trends based on the main standards used for the ESD qualification at component-level: Human Body Model (HBM) and CDM. The shown sensitivity limits are a projection by engineers from leading semiconductor companies. For both qualification standards, no changes are expected until 2030. The current target level for HBM is kept at 1kV and for CDM at 250V.
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on your mark
ANSI Z535.6 – Manuals in Focus
By Erin Earley
I

n our last few “On Your Mark” columns, we’ve been putting a spotlight on the American National Standards Institute (ANSI) Z535 standards. This family of U.S. voluntary consensus standards was created to enhance safety communication and promote consistent hazard recognition and understanding – making it important for manufacturers and workplaces across the country. These standards create a guide for the design, application, and use of signs, colors, and symbols intended to identify and warn against hazards and for other accident prevention purposes. Our theme of exploring each of these standards individually continues, this month focusing on ANSI Z535.6 – Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.

What is ANSI Z535.6?
ANSI Z535.6 is a standard developed by ANSI specifically focusing on the inclusion of safety information in product manuals and other related materials to enhance user understanding and safety. This standard – ANSI Z535.6 Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials – provides guidelines for the design and location of product safety messages in collateral materials. Similar to the other ANSI Z535 standards, it’s intended to apply to a broad range of products.
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