Wendy Fuster explains how F2 Labs is helping manufacturers meet regulatory standards and produce safe products.
Expert Bio:
Wendy Fuster has a BS in Electrical Engineering from the University of Maryland. She cofounded F2 Labs thirty years ago and currently serves as its President. F2 Labs is an ISO 17025 accredited and FDA ASCA regulatory compliance laboratory that specializes in EMC, electrical safety testing, and environmental evaluations. F2 has extensive experience testing medical devices, household appliances, machinery, toys, laboratory devices, industrial machinery, Information Technology (IT) equipment, and radio communications equipment. F2 Labs has specialized laboratories in various locations across the United States.
Q: Can you share with us some of the work you do for F2 Labs and what brought you to your current position there?
A: My husband and I founded F2 Labs in 1992. After I graduated from the University of Maryland in 1989, I joined my husband’s computer manufacturing firm. Soon after joining, the firm shifted from being a reseller to a self-branded systems integrator. The transition demanded numerous new regulatory approvals, which became my responsibility and with which I had no experience.
The labs I consulted took too long to provide quotes and complete their work, and moreover, they provided little to no guidance as to how the process worked, how to prepare, or how to respond to challenges that arose. Ultimately, this led us to set up our own testing site.
When my husband’s firm went public in 1998, we retained the laboratory and focused on growing the expertise and capabilities of F2 Labs, which now caters to the compliance testing needs of thousands of equipment manufacturers of all sizes, domestic and global. As the President of F2 Labs I am involved in all aspects of the business, however my passion remains being directly involved in helping clients solve compliance issues. I have never forgotten how it felt to be in that position 30 years ago—for that reason, we center everything we do around being a partner with our clients throughout the process.
Q: What testing does F2 Labs specialize in, and what industries do you typically work with?
A: At F2 Labs,we perform EMC/EMI testing, wireless radio testing, electrical safety testing, and environmental testing on a variety of product types across a multitude of industries. We can perform this testing in our lab or at the client’s facility.
We serve many industries & product types, including but not limited to medical, laboratory, industrial, household appliances, machinery, toys, IT equipment and radio communication equipment. As an FDA Accreditation Scheme for Conformity Assessment (ASCA)-recognized lab, we are highly focused on testing medical devices.
One of the things I love about our work is the variety of interesting equipment we get to test. We were once brought on to test a tiny electronic medical device (pill) that the creators designed to be swallowed by the patient. Conversely, we tested a proton therapy device that was so large the device developers constructed a building around it.
Q: What are some of the types of electrical safety standards that you cover, and how long do electrical safety evaluations typically take?
A: A safety evaluation is more of a process than you might think: The standards are exhaustive— commonly hundreds of pages long—and require numerous tests and a deep dive into your design documentation. Regulators write different safety standards for different types of products, leading to the publication of thousands of standards. We test to, and are accredited for, a vast number of standards covering the equipment types mentioned above. Some of the more common International Electrotechnical Commission (IEC) standards are 60601-1 (medical), 61010 (laboratory), 60335 (household appliances), and 62368 (information technology). Electrical safety standards are comprised of both constructional and documentation requirements, as well as physical tests that must be performed.
Any way you can think of—and many ways you can’t—that a specific piece of equipment might hurt a user is most certainly covered by the standard. If I plug this in and turn it on, could it electrocute me? Could it overheat and start a fire or burn someone who might touch it? What if I stick my finger in that opening—is there access to live or moving parts that could hurt me? If I drop it and it breaks, could there be sharp edges or access to live parts? Questions like these and many others are built into the comprehensive standards we use today.
Q: What are some of the major regulatory requirement changes you’ve seen in the industries you work with?
A: It can be challenging for manufacturers to determine what standards apply to their devices. Even when manufacturers think they have gotten it right, standards are frequently updated. And testing against an outdated standard can result in your device being not only unmarketable but also unsafe. All standards are constantly being improved/reconsidered, and new standards are regularly released to accommodate either new technology or novel ways of using existing technology.
One current example of how regulations are shifting concerns common EM (electromagnetic) emitters. The FDA now requires electrical medical device manufacturers to show how their devices are immune to such emitters that are not accounted for in the standard tests of IEC 60601-1-2. This new requirement makes sense since modern electronic medical devices are likely to be subjected to a wide variety of novel emitters, such as electrosurgical devices, X-ray devices, metal detectors, wireless power transfer devices (WPT), and 5G cellular signals in both FR1 and FR2 bands. Even so, it can be a challenge for manufacturers to successfully convince the FDA how this may affect their medical devices. We have acquired special test equipment and developed testing methods that analyzes the effects of many of the common EM emitters, and we have been using these to test our customer’s products. Using our proprietary method ultimately saves our clients time and money, and our test reports for this have been accepted by the FDA.
Q: What practical measures should researchers and product developers take to ensure their EMC and safety testing is done efficiently and successfully?
A: By the time our clients prepare to start regulatory testing, they are nearing the end of the product development cycle. At that point, they are typically under pressure to maintain a specific schedule. Even though it is tempting to rush into testing, it will only make things take longer if they are not actually ready. Having your documentation and samples ready to go is crucial if you want your project to go smoothly.
Documentation
In order to perform an electrical safety evaluation, we need to collect quite a bit of documentation, which may include electrical schematics, component information, mechanical drawings, user manuals/instructions for use, labels, etc.
Clients often underestimate the importance of documentation, which consumes more time during electrical safety evaluations than the actual testing. Organized and complete documentation at the outset ensures a smoother and quicker evaluation process.
Pre-compliance testing and evaluation
Many clients overlook—or have not included in their budget—pre-compliance testing and pre-evaluations, which are great ways to find and correct any obvious issues early. Failure to accommodate pre-compliance testing and pre-evaluations can wreak havoc on a test schedule later in the process. Interestingly, even though it adds cost to the overall regulatory budget, it will likely save time and money in the big picture.
Q: How much does EMC and electrical safety testing cost, and why is it so expensive?
A: The cost of testing is obviously an important consideration for manufacturers; it is determined by how much engineering time will be needed to complete the necessary work. It varies depending on the quoted standard and the complexity of the device being tested.
Sometimes, clients tell us that they are surprised by the cost of testing. The testing that we do is complex, and the equipment and laboratory space needed is expensive to purchase, calibrate, maintain, and upgrade when the standards change. Furthermore, our engineers often require years of training to gain the expertise needed to perform these evaluations, and the evaluations themselves often take not just hours, but days or weeks of work.
Are you looking for EMC and electrical safety testing?
Electrical safety and EMC testing is a comprehensive process that should be planned for as early as possible. Whether you are only at the early stage of product development or ready to begin the safety testing process, F2 Labs is prepared to help make EMC and electrical safety testing as smooth and efficient as possible by providing the services and expertise you need. View their services and submit a request through ContractLaboratory.com.
