In an effort to stay current with new and updated international standards, the U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

In a Final Rule published in early February in the Federal Register, the FDA amended its current good manufacturing practice (CGMP) requirements for its quality system (QS) regulation applicable to medical device manufacturers. The amended requirements now incorporate by reference ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. The FDA says that the change is part of its effort to harmonize its quality management systems requirements for medical devices with those adopted by other regulatory agencies.

The FDA’s final rule regarding the changes to its current CGMPs takes effect on February 2, 2026. Until then, device manufacturers must continue to comply with the FDA’s QS regulation.

Read the FDA’s quality system regulation amendment as published in the Federal Register.

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Signal Hound announced it is expanding its physical presence by doubling the footprint at their southwest Washington headquarters by 11,000 square feet.

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SCHURTER has introduced its new MSM II AE Metal Line indicator series, designed to complement its recently launched MSM II Metal Line pushbutton switch series.

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The U.S. and the European Union have signed an agreement to work collaboratively to strengthen the cybersecurity of Internet-of-things (IoT)-capable hardware and software products used by consumers.

The post U.S. and EU Sign Joint Cybersafe Products Action Plan appeared first on In Compliance Magazine.

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.

The post FCC Makes AI-Generated Robocalls Illegal appeared first on In Compliance Magazine.

This blog explains CDM ESD testing using the field-induced (FI) method, which is important for semiconductor manufacturers. It covers building a CDM-FI tester, waveform details and verification, and qualification nuances. 

The post Product Insights: Charged Device Model ESD Testing appeared first on In Compliance Magazine.

The U.S. and the European Union (EU) have signed an agreement to work collaboratively to strengthen the cybersecurity of Internet-of-things (IoT)-capable hardware and software products used by consumers.

According to a joint press statement issued in late January by the European Commission and the White House National Security Council, the Joint Cybersafe Products Action Plan is intended to foster technical cooperation between the U.S. and the EU, in an effort to align their respective cybersecurity requirements. The ultimate goal of the Joint Action Plan is for the signatories to achieve mutual recognition of cybersecurity labeling programs and regulations for IoT devices.

The Joint Cybersafe Products Action Plan was immediately endorsed by Jessica Rosenworcel, Chair of the U.S. Federal Communications Commission (FCC). In a separate statement, Rosenworcel referenced the FCC’s efforts to establish its own cybersecurity labeling program, building on work by the National Institute of Standards and Technology (NIST), and welcomed the opportunity to actively collaborate with their counterparts in the EU to reduce unnecessary cyber risks for consumers.

Read the joint press statement issued by the U.S. and EU about the Joint Cybersafe Product Action Plan.

Read Rosenworcel’s remarks about the U.S./EU Action Plan.

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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, individual consumers are empowered under the TCPA to bring lawsuits against robocallers.

The Declaratory Ruling, which takes immediate effect, is based in part on a Notice of Inquiry issued by the Commission in November 2023 to solicit public input on how AI and AI-influenced technology can or will impact calling and texting processes and the extent to which such technology could compromise consumer privacy under the TCPA.

The FCC’s decision to make AI-generated robocalls illegal also has the support of a coalition of 26 State Attorneys General across the U.S., who urged the FCC earlier this year to restrict the use of AI in marketing phone calls.

Read the FCC’s Declaratory Ruling on AI-generated robocalls.

The appeal from the State Attorneys General supporting the FCC’s action is summarized in a press release issued by the Pennsylvania Attorney General.

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Introduction

The charged device model (CDM) electrostatic discharge (ESD) testing is useful in recreating the potentially destructive discharge mechanisms in automated component handling systems and similar situations where semiconductor devices are packaged and assembled. In these situations, the component becomes highly charged and is then quickly discharged when it encounters a conductive object that is at a lower electrostatic level. This encounter often results in dielectric breakdown and failure of the component. Since this event involves a low-impedance, metal-to-metal transfer of charge, with peak currents reaching tens of amperes within a very short amount of time (within nanoseconds), and there are multiple sources of parasitics involved, it is very difficult to reproduce. Therefore, to increase reproducibility and trust in any semiconductor component manufacturer’s claims of ESD robustness encountered in packaging and handling of their device, a standard (reference 1 is an example) was established to clearly define field-induced CDM ESD test methods for these devices.

Purpose of a Standard CDM ESD Test Method

A standard CDM ESD test method aims to establish a test method that accurately reproduces CDM failures and provides dependable, repeatable CDM ESD test conclusions from tester to tester (equipment to equipment), irrespective of component type or packaging. Accurate classification and comparison of the CDM ESD sensitivity (susceptibility) levels of different semiconductor components is possible by obtaining reliable test data from this standardized CDM test method.

CDM ESD Tester

The normative section of the standard (reference 1) describes the “field-induced” (CDM-FI) CDM test method. One of the informative annexes describes an alternative “direct-contact” (CDM-DC) method. However, the CDM-DC method does not produce results that compare well with results using the hardware and field-induced method specified in the body of the standard, so this CDM test method is not described further in this article.

The CDM-FI tester assumes the use of a resistive current probe. A field plate sits at the bottom of the tester, on top of which sits a dielectric layer. The device under test (DUT) is placed on top of the dielectric layer. Connected to the side of the field plate is a charging resistor (nominally 100 MΩ or greater), and this is connected to switch K1, the purpose of which is to switch between charging the field plate using a high-voltage supply and grounding the field plate.

Placed above the field plate is a ground plate with a hole that allows the pogo pin (ground pin) to protrude through it. The pogo pin is connected to the center conductor of 50Ω coaxial cable, the output of which connects to the 50Ω input of an oscilloscope. The standard specifies the pogo pin to ground plane connections as a 1 Ω current path with a minimum bandwidth (BW) of 9 gigahertz (GHz). These two items make up what is called the current-sensing element in the standard. The entire ground plate is connected either to ground or to the field plate through the high-voltage supply, depending on the position of switch, K1.

Waveform Characteristics

Waveform characteristics are specified without additional passive or active devices (such as ferrites) in the probe’s assembly. This requirement may affect compliance of existing CDM-FI testers which might have used components like ferrites to obtain the correct waveforms. If you have a CDM-FI tester built before 2017, consult your CDM ESD tester manufacturer to see if this requirement is an issue.

For exact waveform requirements of the standard, refer to Figure 2 – CDM characteristic waveform and parameters, Table 1 – CDM waveform characteristics for a 1 GHz bandwidth oscilloscope, and Table 2 – CDM waveform characteristics for a high-bandwidth (≥ 6 GHz) oscilloscope).

Parasitics

For anyone building their own CDM-FI tester, the standard cautions about the potential for having too large of parasitics in the charge and discharge paths because having these unwanted resistance inductance-capacitance (RLC) parasitics in the equipment will greatly influence the test results and comparison of these results with those obtained from complaint CDM-FI testers.

Specifications for Various Elements of the CDM-FI

Exact specifications for each part of the CDM-FI are described in detail in the standard and are not repeated here. This includes exact specifications for the current-sensing element (resistance plus/minus tolerance, frequency response, and maximum roll-off), dimensions of the ground and field plates (plus/minus tolerance, surface flatness), material composition and thickness (plus/minus tolerance) for the dielectric layer, etc.

Common CDM ESD Test Standards

Other CDM ESD test standards often encountered in the industry include JS-002, AEC-Q100-011, AEC-Q101-005, and JESD22-C101. Reference 1 is based on ESDA/JEDEC Joint Standard ANSI/ESDA/JEDEC JS-002, which resulted from merging JESD22-C101 and ANSI/ESD S5.3.1. Reference 1 contains the essential elements from these original CDM ESD standards, and cooperation between ANSI, ESDA, JEDEC, and the IEC took place in creating reference 1.

Qualification and Verification of the CDM-FI Tester

The standard requires periodic tester qualification, waveform records, and waveform verification, i.e., “The CDM tester shall be qualified, re-qualified, and periodically verified….”

Any change to the main elements of the CDM-FI tester (described previously) requires waveform verification. Luckily, the standard provides what waveform capture hardware is required along with the waveform capture setup and procedure. The standard also provides a detailed qualification/requalification procedure that appears easy to follow. The standard states: “Maximum time between requalification tests is one year.” Suppliers of CDM-FI testers may have their own recommendations for requalification that savvy users of the equipment will follow.

Pro Tip: If you have ever been caught in a situation where you potentially have shipped a non-compliant product because you later found out your tester was not producing the correct output waveform (not a fun situation), you will want to develop a process to re-check your CDM-FI tester’s waveform characteristics as often as feasibility justified (perform a cost/benefit and risk analysis to determine your best options).

Summary

This article described the basics of CDM ESD testing using the FI method and why it is important to those who produce semiconductor devices. It included the construction of a CMD-FI tester, some of the nuances involved, and proper qualification and verification of its waveform. Hopefully, you find this information useful.

References and Further Reading

1. IEC 60749-28:2017, Semiconductor devices – Mechanical and climatic test methods – Part 28: Electrostatic discharge (ESD) sensitivity testing – Charged device model (CDM) – device level.

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This month's blog explains X-type capacitors, which suppress emissions in switch-mode power supplies and variable drives.

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This month's blog explains X-type capacitors, which suppress emissions in switch-mode power supplies and variable drives.

The post Practical Engineering: X1 vs X2 Capacitor Types and How to Select the Correct Type appeared first on In Compliance Magazine.

The EU Commission has proposed providing manufacturers of certain medical devices with additional time to comply with the requirements of the EU’s IVDR.

The post EU Commission Proposes More Time for Compliance with In Vitro Diagnostics Regulation appeared first on In Compliance Magazine.

The FCC has recently published new guidance to provide further clarification around the requirements that apply to space satellite operators under the agency's existing orbital debris mitigation rules.

The post FCC Adopts Guidance on Orbital Space Debris appeared first on In Compliance Magazine.

Background Information

X-type capacitors suppress differential mode conducted emissions in applications such as switch-mode power supplies, DC-DC converters, variable-speed motor drives, and other similar devices. The X designation means they are applied line-to-neutral, as shown in the simple diagram below.

The Issue

Manufacturers of X capacitors have their capacitors tested and certified by a Nationally Recognized Testing Laboratory (NRTL), and a certificate is provided. X-type capacitors are considered a safety critical component of the end-product, and as a compliance engineering professional, it is crucial that you know which subclass to use. Not selecting the correct sub-class for the end-products’ application will result in a non-compliance that will cause re-design and delay of production release of the product. Switching is not a simple process if you select an X2-rated capacitor and need an X1 instead. First, you must find a suitable X1-rated part and try to make it fit into the existing design. X1-rated capacitors are physically bigger than X2-rated parts.

X-type Capacitor Subclasses

The standard most often used to certify X (and Y) capacitor types is IEC 60384-14. This standard specifies three different subclasses of X-type capacitors depending on their peak impulse voltage rating.

X3 Subclass

The subclass X3 has a peak impulse voltage rating of less than or equal to 1.2 kV. This is not too high of an impulse rating, so only use X3-rated capacitors in benign environments (those protected from overvoltage transients). Since it is not to be used for robust design, the X3 subclass is not discussed further in this post.

X2 Subclass

The subclass X2 has a higher peak impulse voltage rating than the X3 type. The X2 subclass has a peak impulse rating of less than or equal to 2.5 kV.

X1 Subclass

Finally, the subclass X1 is even more robust than the X2 capacitor type. It has a peak impulse rating of greater than 2.5 kV and less than or equal to 4.0 kV.

Which Subclass Type Do I Use? X1 or X2?

To determine which subclass type to use (X1 or X2), you must know the end-product’s overvoltage category of the intended environment. This is something that is usually determined early in the product development cycle.

IEC 60664-1 (latest edition is dated 2020) describes the overvoltage categories. There are four overvoltage categories, designated as I, II, III, and IV. Devices installed in category IV locations are subjected to the most severe transients (surges), whereas category I locations are the least severe, protected environments. This post focuses on categories II and III. Examples of category II locations are household appliances plugged into the standard home wall outlet. Category III locations are closer to the voltage supply and subjected to harsher transient conditions. Examples are switches in the fixed installation and equipment for industrial use with permanent connection to the fixed installation.

Annex B (informative) of IEC 60664-1 describes nominal voltages of mains supply for different modes of overvoltage control. See Table B.1 – Inherent control or equivalent protective control. This table is something you need to look at.

For example, select 300V as the voltage line-to-neutral derived from nominal voltages AC or DC. The rated impulse withstand voltage for the equipment is provided for each overvoltage category. For category II, it is 2.5 kV; for category III, it is 4.0 kV.

Given this information, if your end-product is installed in an overvoltage category II location, then an X2-rated capacitor is acceptable. However, if it is installed in an overvoltage category III location (a location that requires a rated impulse withstand voltage of 4.0 kV), then an X1-rated capacitor is required.

What If I Select an X2 but Require an X1?

All is not lost if you inadvertently select an X2-rated capacitor but require an X1. You can install a clamping device (such as a metal oxide varistor) across the line that limits the transient overvoltage seen by the rest of the circuit to less than or equal to 2.5 kV and work with your NRTL to accept it. This workaround has some risks as it depends on the NRTL’s policy for dealing with this situation, which could change anytime.

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The Commission of the European Union (EU) has proposed providing manufacturers of certain medical devices with additional time to comply with the requirements of the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR).

Originally published in 2017, the EU’s IVDR established a new regulatory framework applicable to in vitro devices (IVDs). Requirements under the IVDR are scheduled to take effect in May 2025 for high-risk IVDs and May 2027 for lower-risk devices.

However, according to a press release issued in late January, the Commission is concerned that many IVDs currently on the market still do not comply with the new requirements, including a number of what it classifies as high-risk IVDs used to test for infections in blood and organs.

Accordingly, the Commission has proposed extending deadlines for compliance with the IVDR requirements as follows:

• For Class D devices, including high individual and public health risk devices such as HIV or hepatitis tests, a deadline of December 2027;
• For Class C devices, including high individual and/or moderate public health risks devices such as cancer tests, a deadline of December 2028; and
• For Class A and B devices, including lower-risk devices such as pregnancy tests and blood collection tubes, a deadline of December 2029.

According to the Commission’s press release, their proposal to extend the IVDR transition deadlines will now go to the EU Parliament and Council for their review and adoption.

Read the EU Commission’s press release detailing its proposed changes to the implementation dates of the IVDR.

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The U.S. Federal Communications Commission (FCC) has issued a guidance to clarify requirements for space satellite operators under its orbital debris mitigation rules.

In an Order on Reconsideration issued at the end of January, the Commission addresses a number of questions posed by satellite operators and other petitioners about its debris mitigation requirements. Specifically, the Order addresses questions dealing with satellite maneuverability disclosure requirements and the use of “free-flying” deployment devices.

The Order also offers guidance on methods that can be used by satellite operators to conduct re-contact risk analyses, as well as its requirements for assessing and limiting the release of persistent liquids in space.

These latest actions by the Commission are intended to support continued investment and innovation on the deployment of space-based services, consistent with its Space Innovation agenda, while also taking steps to advance space safety.

Read the FCC’s Order on Reconsideration on orbital space debris.

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To help support the further deployment of broadband technologies and services, the U.S. Federal Communications Commission (FCC) has amended its spectrum rules to facilitate access to broadband services on aircraft and on ships.

The updated rules were codified in a Report and Order adopted by the Commission in late January and authorize certain point-to-point links to “endpoints in motion” in the 70 and 80 GHz bands. The updated rules also allow for the use of smaller and lower-cost antennas to support backhaul services in these bands.

Finally, the Commission has changed the link registration process in the 70/80/90 GHz bands to require certification of registered links. The Commission says that this change will promote more efficient use of the applicable spectrum while also improving the accuracy of the link registration database.

In addition to its Report and Order, the Commission has also adopted a Further Notice of Proposed Rulemaking, seeking public comment on a proposal to add another type of link for maritime operations, as well as a proposal to include Fixed Satellite Service earth stations in the revised light-licensing process for the 70/80 GHz bands.

Read the FCC’s Report and Order and Further Notice of Proposed Rulemaking on expanding access to the 70/80/90 GHz bands.

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The U.S. Federal Communications Commission (FCC) has submitted to the U.S. Congress its annual report on the agency’s efforts in 2023 to reduce the incidence of illegal radio broadcasts.

Mandated under the provisions of the Preventing Illegal Radio Abuse Through Enforcement (PIRATE) Act, the January 24th report summarizes actions that the FCC took in 2023 to implement the Act’s provisions. These include enforcement efforts against property owners and managers, a streamlined process for notifying parties of violations, increased maximum forfeitures for pirate radio broadcasting, and increased educational outreach efforts. The report also provides details on a number of specific enforcement actions it took against pirate radio operators in 2023.

The FCC’s report to Congress also notes that 2023 was the first full year in which the Enforcement Bureau conducted annual enforcement “sweeps” in five markets across the U.S. with the largest number of pirate radio operations. In addition, the Commission has worked to develop customized mobile direction-finding (MDFX) investigative vehicles to assist Field Agents in conducting their investigations of complaints about illegal radio operations and will take delivery of six vehicles over the next two years that will include specialized signal detection hardware and software.

Read the FCC’s annual report to Congress on its pirate radio enforcement efforts in 2023.

 

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As a product designer, one of the biggest issues you’ll face is radiated emissions. This month, we’ll describe the minimal set of tools to characterize and help mitigate radiated emissions right on your workbench.

Near Field Probes

Most designers may be familiar with near field probes but may not understand how to go from using them to identify “hot spots” of high harmonic energy within your board or system to actually mitigating the issues.

These can either be constructed as DIY projects or commercial probe kits may be purchased. Flexible or semi-rigid coaxial cables may be used. H-field (loop) probes may be constructed by soldering the center conductor to the shield, as in Figure 1. An E-field probe may be constructed by cutting away a short (5mm) portion of the shield, exposing the center conductor. Both types of DIY probes should be dipped in rubberized “tool dip” or otherwise insulated to avoid shorting out circuitry. See the example in red.

More details for commercial product choices can be found in Reference 1 at all price points. Each month, we’ll be using this basic equipment for some hands-on experiments we can do together.

Let’s start off with the most basic probe; E-field (voltage measurement) and H-field probes (current measurement). These are designed to be most sensitive to either E-fields or H-fields, respectively.

Figure 1: Some DIY H-field probes. The smaller one may require a broadband preamplifier to observe usable harmonics.

H-field probes are most sensitive to currents in wires or cables. While these DIY versions have an unbalanced geometry, which creates common mode currents flowing up the “handle” portion, they are still useful for general troubleshooting.

E-field probes are more sensitive to components that create large E-fields, such as heat sinks and any circuit switching large voltages. A good example of large changing voltages would be off-line switching power converters.

Figure 2: A variety of commercial H-field probes. Rohde & Schwarz, Com-Power, Tekbox and Beehive Electronics (top to bottom).

 

The advantage to commercial near field probes is that they are insulated and, being longer and thinner, can penetrate into narrow spaces (Figure 2). Commercial probes come as sets, usually three H-field probes in different sizes and an E-field probe.  Beehive Electronics and Tekbox probe sets are about $350. Make sure to order the cable (sold separately) for the Beehive probes.

Com-Power probe sets include a capacitive-couple probe that can directly measure harmonic voltages on circuit traces and can also be used to inject signals useful for troubleshooting immunity issues. The Rohde & Schwarz probe set is unique in that, in addition to the usual H- and E-field probes, they also include some very tiny probes that may be more useful in today’s small wearable products.

Near field probes are most useful for identifying major energy sources on PC boards and internal cables. I use H-field probes for detecting high currents (as in ICs and circuit traces) and E-field probes for detecting high voltage swings (as in buck converters). A record of the harmonic spectrum for each major energy source should be recorded.

RF Current Probes

The reason most products fail radiated emissions is that their attached cables carry high-frequency harmonic currents, which tend to make them radiate as transmitting antennas. Note that it takes only 6 to 8 µA of high-frequency harmonic currents to exceed the FCC or EU limit for Class B (household) products!

By measuring and monitoring these RF currents, we can often perform troubleshooting right on our workbenches and mitigate emissions prior to taking the product to the compliance test lab. Reducing these RF currents will also reduce the cable emissions.

While I personally own several commercial current probes, those pictured in Figure 3 are the ones I started out with for a couple of years before I could afford a good set. Many of my clients are helped remotely, and I’ve had them make these DIY probes so I can guide their troubleshooting efforts.

Choose a ferrite that has some impedance in the frequency range of most common mode currents: 30 to 200 MHz. A Fair-Rite choke made from type 31 material, or equivalent, should work well. The number of turns is not critical, and I usually use 5 to 7 turns. Terminate with the desired coaxial connector epoxied in place. Be aware the hinge on these DIY current probes won’t last forever, so be prepared to replace them occasionally.

Figure 3: A couple of DIY RF current probes made from standard clamp-on ferrite chokes.

The fact these DIY probes are uncalibrated is unimportant when used for troubleshooting purposes since we’re only looking for relative changes. For example, if we know we’re failing by 5 dB, then at the workbench, we’ll want to apply mitigations to reduce the harmonic amplitude by 10 to 15 dB for safety.

Eventually, you’ll want to purchase a calibrated RF current probe. Figure 4 shows an affordable commercial probe from Com-Power. Similar affordable probes are available from Tekbox. Be sure to order one that can clamp around the wire or cable to be tested.

As for the near field probes, you’ll want to record the harmonic frequency spectrum for each cable attached to your product. By examining the cable currents, you should find some correlation to the energy source or sources on the board or interior cables. Part of the mitigation process will be to identify and reduce the coupling between the dominant energy sources and radiating cables.

Figure 4: An example of a commercial RF current probe that is calibrated from 10 kHz to 400 MHz. Photo, courtesy Com-Power.

Nearby Antenna

Once your product is characterized using the near field and current probes, I usually switch to a nearby antenna placed about 1m from the product under test. The resonant frequency doesn’t matter much so long as you can observe the harmonics from the EUT. Monitoring the actual emissions while troubleshooting and applying mitigations in real-time is a very efficient way to resolve design problems.

Figure 5: Monitoring the emissions from the product under test with a spectrum analyzer and simple antenna is a very efficient method for fixing problem harmonics.

The antenna I like to use is made by Kent Electronics and costs just $38. I show how to make the PVC fixture that attaches to a table-top tripod in Reference 2.

Spectrum Analyzers

In recent years, the cost of spectrum analyzers has dropped to very affordable levels. I started my career with a Rigol DSA815TG, which was about $1,500 at the time. Since then, this price has dropped to about $1,000. I’m currently using the Siglent SSA 3032X, with its larger screen.  If you’re in the market for one of these, be sure to order the tracking generator and EMI options, as we’ll be using these for more advanced EMC characterizations.

There are several other good choices in analyzers, and Rigol and Siglent have captured much of the affordables market. Many other alternatives are described in Reference 1. The U.S. distributor for these models is Saelig Electronics.

Summary

This summarizes the most basic equipment needed for identifying the major harmonic noise sources and for characterizing radiated emissions. Next month, we’ll use these tools to help characterize some actual embedded processors and suggest some mitigations that would improve the designs.

References

1. Wyatt, Create Your Own EMC Troubleshooting Kit (Volume 1, 2nd Edition), Amazon, 2022.
2. Wyatt, “PC Board Log Periodic Antennas,” EDN.

 

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Tech giant Apple Corporation has recently filed a patent application for wearable devices that use novel sensors to track essential physical characteristics in humans.

According to a recent article posted on the “Patently Apple” website, the application filed with the U.S. Patent and Trademark Office seeks intellectual property protection for “wearable devices that include interferometric sensors, such as self-mixing interferometry (SMI) sensors.” The sensor system would “provide users with respiration information such as respiration rate, respiration quality, information about nasal congestion, information about snoring, airflow velocity and more.”

The patent application also includes “a new wearable device in the form of a health mask,” which could provide users with important health information.

Read the “Patently Apple” article on Apple’s newly developed interferometric sensor system.

A copy of Apple’s patent application is available for download from the website of the U.S. Patent and Trademark Office.

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