In Compliance: The Compliance Information Resource for Electrical Engineers logo
Implementing Robust Watchdog Timers for
Embedded Systems
Including
Recalls Can Create a Multitude of Legal Problems

Developing the Dynamic Hazard‑Based Safety Engineering by Introducing the Control-Oriented Model

EMC Concepts Explained

Hot Topics in ESD

Troubleshooting EMI Like A Pro

On Your Mark

Close-up view of a printed circuit board with black chips and gold pathways.
Including
Recalls Can Create a Multitude of Legal Problems

Developing the Dynamic Hazard‑Based Safety Engineering by Introducing the Control-Oriented Model

EMC Concepts Explained

Hot Topics in ESD

Troubleshooting EMI Like A Pro

On Your Mark

May 2025
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May 2025
Volume 17 l Number 5
Contents
Feature Articles
By Christopher James Semanson, Senior Contributor
By Kenneth Ross, Senior Contributor
Columns
By Bogdan Adamczyk, Patrick Cribbins, and Khalil Chame
By Eleonora Gevinti, Michael Khazhinsky, Ali Muhammad, Dolphin Abessolo Bidzo, Nicolas Richaud, Peter Koeppen, Kuo-Hsuan Meng, Vladislav Vashchenko, Andrei Shibkov, and Matthew Hogan, WG18 on behalf of EOS/ESD Association, Inc.
By Erin Earley
Departments
compliance news
FDA Warns Against Unauthorized Modifications to Medical Devices
The U.S. Food and Drug Administration (FDA) is stepping up its efforts to identify FDA-cleared medical devices that have been subsequently modified and that no longer fall within the scope of their original clearance.

An article posted to the website of JD Supra summarizes a recent FDA investigation of the facility of a California-based medical device manufacturer (Q’Apel Medical, Inc.), during which inspectors identified several concerns regarding a previously cleared medical device. The issues included design modifications and misbranding concerns, each of which required the company to obtain…

FCC to Investigate CCP-Aligned Entities
The U.S. Federal Communications Commission (FCC) has launched a major investigation into entities operating in the U.S. that are aligned with China’s Communist Party (CCP) and whose communications equipment has been placed on the FCC’s Covered List.

According to a press release issued by the Office of FCC Chair Brendan Carr, some of the entities on the Covered List may still be operating within the U.S., in violation of the prohibitions under FCC regulations. The FCC has already sent Letters of Inquiry to each of the listed entities to determine what, if any, further actions are required…

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Feature Article
Implementing Robust Watchdog Timers for Embedded Systems
Design Principles, Configuration Strategies, and Fault Recovery Methods Using Watchdogs for Modern Systems
By Christopher James Semanson, Senior Contributor
close up of a black and white circuitry board
W

atchdogs have long been a standard, if slightly esoteric, element of system design, often receiving only secondary consideration after the primary application has been planned out. At their core, they serve a straightforward purpose: providing a graceful means of recovery in the event of abnormal system behavior. At their origin, watchdog timer architectures were simple, implemented via a dedicated application-specific integrated circuit (ASIC), positioned adjacent to the system’s processor (see Figure 1).

In that early form, interaction with the watchdog was typically limited to a simple general-purpose input/output (GPIO) pin. However, as systems have grown in complexity and adopted stricter safety requirements, watchdog implementations have also evolved. In more modern setups (see Figure 2), a watchdog may be integrated into the microcontroller itself, reside in a voltage monitor or supervisory device, or be part of a power management integrated circuit (PMIC), often refreshable through GPIO, I2C, or SPI.

Feature Article
Recalls Can Create a Multitude of Legal Problems
Minimizing These Problems Can Be Difficult
By Kenneth Ross, Senior Contributor
gavel on top of a stack of folders
W

hen a recall is implemented, it hopefully solves the safety issue. But that doesn’t always happen. First, you rarely are 100% successful in retrieving the product or repairing it. And, of course, the occurrence of an accident involving a recalled product can be very difficult to defend. Even worse, an accident involving a product that was unsuccessfully repaired by the manufacturer can be even harder to defend.

The number of lawsuits involving recalled products and products that haven’t been recalled has been proliferating recently. And the verdicts and settlements have been significant.

This article will describe the difficulty of defending the adequacy of a recall, the types of remedies that are offered, and a recent trend of class action lawsuits being filed alleging that the remedy instituted by the manufacturer is inadequate and resulted in economic loss to the consumer or owner of the product.

Defending the Adequacy of the Recall
Injuries or deaths resulting from unsuccessful recalls or repair programs can result in litigation and huge verdicts. It can be difficult to argue that a 10% response rate was adequate and could not be improved by the manufacturer doing more. In that case, the jury could believe that the manufacturer negligently performed the recall.

In addition, if a repair is performed and an accident still occurs, that can also cause a jury to get mad and believe that the manufacturer was grossly negligent. In August 2024, a jury rendered a huge award against Harley-Davidson for allegedly failing to adequately repair faulty software on one of its recalled motorcycles. Unfortunately, there was an accident on the repaired motorcycle that resulted in catastrophic injuries and one death. The jury awarded $240 million in punitive damages and $47 million for pain and suffering, medical expenses, and loss of consortium.

Of course, Harley believes that the accident had nothing to do with the original repair and they plan to appeal. The message here is that if you repair or replace the product instead of refunding the purchase price, you had better be confident that the fix or replacement is adequate and that you have good evidence that it is safe.

Feature Article
Developing the Dynamic Hazard-Based Safety Engineering by Introducing the Control-Oriented Model
By Shun Zhang, Haiwen Lu, Brent Taira, and Daniel Barsotti
business man sitting at table with hands out on each side of a yellow caution triangular sign
Editor’s Note: The paper on which this article is based was originally presented at the 2024 IEEE Product International Symposium on Product Compliance Engineering (ISPCE), held in Chicago, IL in April-May 2024, where it received the 2024 Best Paper Award. It is reprinted here with the gracious permission of the IEEE. Copyright 2025, IEEE.
Introduction
The International Electrotechnical Commission (IEC) has established the IEC 62368-1 standard, grounded in hazard-based safety engineering (HBSE) principles, as a pivotal framework for the design and evaluation of audio, video, and information and communication technology (ICT) equipment. HBSE emphasizes the identification and mitigation of risks by evaluating the safety of a product under normal operating, abnormal operating, and single-fault conditions, as well as acknowledges a variety of potential hazards. This standard organizes energy sources into categories—electrical energy sources (ES), thermal energy sources (TS), mechanical energy sources (MS), radiation energy sources (RS), and power sources (PS)—based on their capacity for energy transfer and potential harm [1-2].

IEC 62368-1 addresses numerous hazards, including electric shock, mechanical, heat, radiation, chemical, and fire risks. Yet, its current iteration primarily presumes that safety mechanisms are built-in or are physical hardware safeguards, with minimal explicit focus on control-based safety, especially where hazard prevention significantly depends on or is facilitated by software. In the digitalization and Internet of Things (IoT) era, where software increasingly governs devices—including vital safety functions like overtemperature protection, fire prevention, and other types of hazard monitoring and control—this oversight in considering software’s role in safety assurance demands thorough examination [3‑4].

EMC concepts explained
Inductor Impedance Evaluation from S-Parameter Measurements
Part 2: S21 Two-Port Shunt and Two-Port Series Methods
By Bogdan Adamczyk, Patrick Cribbins, and Khalil Chame
T

his is the second of two articles devoted to the topic of inductor impedance evaluation from the S parameter measurements using a network analyzer. The previous article [1] described the impedance measurements and calculations from the S11 parameters using the one-port shunt, two-port shunt, and two-port series methods. This article is devoted to the impedance measurements and calculations from the S21 parameters using the two-port shunt and two‑port series methods.

The overall conclusion of the previous article was that the inductor impedance evaluation from the S11 parameter measurements is not accurate. This article concludes that the two-port series method is the most accurate method for the inductor impedance evaluation from S21 parameters when using a network analyzer.

Two-Port Shunt Method
The two-port shunt configuration is shown in Figure 1.
hot topics in ESD
Why ESD Electronic Design Automation Checks are So Critical: Part 1
On behalf of EOS/ESDA Association, Inc.
By Eleonora Gevinti, Michael Khazhinsky, Ali Muhammad, Dolphin Abessolo Bidzo, Nicolas Richaud, Peter Koeppen, Kuo-Hsuan Meng, Vladislav Vashchenko, Andrei Shibkov, and Matthew Hogan, WG18
A

new version of Technical Report TR18.0-01-25 (TR18) on ESD Electronic Design Automation (EDA) Checks by the ESD Association’s Working Group 18 is about to be released. This article provides an overview of TR18, which offers guidelines for the EDA industry and the ESD design community to establish a comprehensive ESD verification flow. This flow addresses ESD design challenges in modern ICs, including common terminology and required check types. The main requirements are broad check coverage, manual checking limitations, transparency, and integration into the design flow for clear and actionable violation reporting. The document covers generic checks, EDA toolsets, and databases, allowing IC design companies, IDMs, or foundries to implement specific rules in their design and verification flows for automated checking.

ESD Checks Throughout the IC Design Flow
ESD checks for an IC product design are performed at multiple phases throughout the product design. These checks need to be coordinated with the ESD development and implementation flow, supported by an ESD check flow. The main phases of the product design flow are:
  • Technology Enablement Phase
  • Product Definition Phase
  • Product Architecture Phase
  • Product Design Phase
  • Product Verification Sign-off Phase
  • Product Validation Phase
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troubleshooting EMI like a pro
Poor Power Distribution Network Leads to Unexpected Radiated Emissions
By Dr. Min Zhang
R

ecently, I worked on a radiated emissions case involving narrowband emission failures in the 100 MHz to 1 GHz range. Identifying the source of such narrowband noise is usually straightforward, and, in this case, a near-field sniffing probe quickly led us to the culprit: the clock signal of a high-speed SPI line between the microcontroller and the flash drive on the PCB. This is demonstrated in Figure 1.

However, during troubleshooting, I discovered something unexpected—other I/O lines, much slower by nature (such as an I2C line running at just tens of kHz), were also exhibiting the same 100 MHz harmonics. This became evident when I used an RF current probe to measure common-mode noise on the wires connected to the PCB, shown in Figure 2.

To mitigate the noise on the other I/O lines, I initially used high-impedance ferrite beads. When selecting ferrite beads, a simple rule applies:

  • Their impedance should be low enough at the signal’s operating frequency to avoid signal integrity issues and
  • Their impedance should be high at the noise frequency to effectively suppress unwanted emissions.
on your mark
ANSI Z535.7 – Product Safety Information in Electronic Media in Focus
By Erin Earley
F

or those that follow our “On Your Mark” columns, you know the emphasis placed on the value of ANSI Z535 – the U.S. standards that 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. These standards, along with their international counterpart, ISO 3864-2, are effective starting points in helping you to develop adequate warnings. Recently, we had an exciting new development in this family of standards: the release of an all-new seventh standard. In this article, we’ll explore the new standard and how its principles can be used to create effective warnings that drive safety.

A New Standard Enters into the ANSI Z535 Family
The ANSI Z535 standards are commonly used by manufacturers and workplaces across the U.S. as a main guideline for following best practices and creating consistency in their safety warnings and instructions. The family of the ANSI standards (Z535.1 to Z535.6) were republished in 2022 and 2023. In late 2024, ANSI Z535.7 was released, a new ANSI Z535 standard focusing on product safety information in electronic media. Together, these standards – now a family of seven – contain the information needed to specify formats, colors, and symbols for safety signs used in environmental and facility applications, in product and product literature applications, in temporary safety tag and barricade tape applications, and in electronic media.
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