Imagine this: your brand-new, bright, glistening product steps into a chamber. The door closes. Inside, it’s not the day at the spa it expected – instead – it’s a nightmare at the beach. That is Corrosion/Salt Fog Testing..
This testing is basically the same as setting your product outside a seaside condo with no shade, no maintenance, and a hurricane every day… for weeks. Why is this done? To determine if your product can survive in the kind of humid, salty, nightmare that would make even a pelican move inland.
Why We Do It? (Other than because it’s fun)
Because some standards require it and the goal is simple: duplicate years of corrosive exposure in just a few days or weeks. Think of it as time travel, but instead of visiting the Bronze Age, your product is flung into the future, where rust is king. What do we check? • That metal components survive the testing without turning into lace. • That the coating stays on and intact and doesn’t peel off like last week’s sunburn. • That fasteners remain functional, not fuse together in a salty embrace.
Typical standards that require this testing:
• MIL-STD-810H Method 509.7 – Environmental Engineering Considerations for Defense Electronics • IEC 60068-2-11 – Environmental testing – Part 2-11: Tests – Test Ka: Salt mist • ISO 9227 – Corrosion tests in artificial atmospheres — Salt spray tests • UL 50E – Enclosures for Electrical Equipment, Environmental Considerations • NEMA 250 – Enclosures for Electrical Equipment (1000 Volts Maximum)
The Test Setup
A typical salt fog chamber resembles a mix between a fridge, a sauna, and a mad scientist’s fish tank. Inside, your product gets showered with a fine mist of saltwater, usually 5% sodium chloride. That’s the same stuff in ocean water — except here, it’s 24/7 and there’s no “low tide.” Engineers then check the product at intervals. If something is corroding, swelling, cracking, or just generally looking like it’s been rescued from the Titanic… congratulations, you’ve learned something valuable (and probably expensive).
Lessons Learned
Salt fog testing teaches us that:
Nature is undefeated.
A good protective coating is worth its weight in gold (or at least stainless steel).
Just because it survived in the lab doesn’t mean it’ll survive on the Jersey Shore.
Final Thoughts
Salt fog testing is brutal, but it’s also a love letter to durability. By the end, your product will either emerge victorious — battle-scarred but proud — or it’ll be heading back to R&D for a serious armor upgrade.
And hey, at least it got to “visit the beach,” right? Contact Us if you have a product that needs to lounge in the salty air!
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Let’s talk about Essential Performance—the term that sounds like it belongs in a motivational poster but is actually a cornerstone of medical device compliance. If you’ve ever stared at a test plan wondering, “Do I really need to define this?”—this one’s for you.
What Is Essential Performance, Anyway?
According to AAMI CR500, Essential Performance is:
“Performance of a clinical function, other than related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK.”
Translation? If your device stops doing something it’s supposed to do—and that failure could hurt someone—it’s probably Essential Performance.
It’s not about whether the device turns on or doesn’t electrocute anyone (that’s basic safety). It’s about whether it does its job in a way that keeps patients safe.
How Do You Decide What It Is?
Start with your Indications for Use. If your device is just along for the ride (think: adjunct therapy), you might not need to define Essential Performance. But if it’s delivering therapy or doing something critical—buckle up.
Then, do a risk assessment (hello, ISO 14971). Ask yourself:
Pro tip: Don’t get lazy with vague language. “Monitor alarms” doesn’t cut it if your device doesn’t even have alarms. FDA reviewers are not fans of generic fluff.
Common Pitfalls to Avoid
Let’s be honest—this is where things get messy. Here are some classic missteps we’ve seen:
• Skipping the risk analysis: You can’t just say “no Essential Performance” without backing it up. That’s like skipping the fire drill and hoping for the best.
• Using generic criteria: “Device functions as intended” is not a testable metric. Be specific. Be measurable.
• Copy-pasting from other devices: Just because it worked for Device A doesn’t mean it applies to Device B. Context matters.
• Assuming therapy = safety: Delivering therapy doesn’t automatically mean you’ve covered Essential Performance. You still need to define it.
• Ignoring the IFU: Your Indications for Use are the blueprint. If they say “delivers therapy,” you’re on the hook.
When You Can Say “No Essential Performance”
Yes, there are times when it’s okay to say your device doesn’t have Essential Performance. But only if:
• The IFU clearly shows it’s not delivering therapy.
• There are no clinical functions that could cause harm if they fail.
• You’ve documented this with a proper risk-based rationale.
No shortcuts. No, “we just decided not to.” And definitely no “we copied this from another device.”
Real-World Examples
Thermometer – The importance of maintaining a certain accuracy is critical because if a fever goes undetected, then fever reducer would not be given, or the person may have a serious infection go undiagnosed and untreated.
Infusion Pumps – Accuracy is extremely important. Administering too much or not enough of certain medications, such as Chemotherapy Drugs, can pose serious risks.
UV light used to disinfect – If the UV level is too low, then there is the risk of the bacteria or pathogens not being killed and possibly being ingested. If the UV is too high, there is a risk of it burning a material and possibly putting toxic gases into the air.
These aren’t guesses—they’re tied to actual risk and clinical function.
Final Thoughts
Essential Performance isn’t just a checkbox—it’s a safety net. It’s how we ensure medical devices don’t just work, but work safely when it matters most.
So next time you write a test plan or prepare for a submission, ask yourself: What’s essential? Then prove it.
Do you have a device you’re unsure about? Do you need help defining Essential Performance criteria that won’t get flagged by reviewers? Reach out to our compliance team or submit a Contact Us form. We love a good challenge—and we’ve seen it all. Want us to feature your device in a future Tech Note? Let’s talk.
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Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between the two nations intensify, firms must reevaluate their global strategies—particularly when it comes to supply chains, partnerships, and compliance efforts.
Legislative Spotlight: The BIOSECURE Act
At the center of this shift is the proposed BIOSECURE Act, a bipartisan measure in the U.S. Congress. If enacted, it would prohibit federal contracts and funding for organizations that engage with specific Chinese firms—especially those in the biotech and genomics sectors that raise national security concerns. Though still under legislative review, the bill is already influencing corporate behavior, pushing medtech companies to scrutinize their operations for potential exposure to restricted entities.
Currently, five Chinese firms are named under the legislation. Companies would have until 2032 to cut ties with these “entities of concern,” though there’s speculation that the timeline could be shortened depending on how geopolitical conditions evolve. The FDA and FCC specifically are not accepting test results from these Chinese firms and others.
Declining Confidence in Cross-Border Collaboration
Surveys within the life sciences industry reveal a sharp decline in executive confidence when it comes to partnering with Chinese companies. This drop reflects not only regulatory apprehensions but also fears around supply chain vulnerabilities and reputational risks. As scrutiny increases, firms are reconsidering their dependencies on Chinese manufacturing and research entities.
Strategic Recommendations for Medical Device Manufacturers
To prepare for and respond to this changing landscape, medtech companies should take the following steps:
Gain a Clear Understanding of Emerging Policies Familiarize leadership and compliance teams with the BIOSECURE Act and related legislative proposals. Assess current relationships with Chinese suppliers and determine any potential risks to U.S. federal funding eligibility.
Review and Map Supply Chains Conduct a detailed audit of suppliers and subcontractors, paying close attention to ownership structures and geographical affiliations. Transparency across the supply chain will be crucial for future regulatory compliance.
Establish Backup Plans for Operations Diversify sourcing and manufacturing options to reduce overreliance on any single country or region. Building flexibility into logistics and inventory management can help companies adapt quickly to regulatory or trade disruptions.
Strengthen Cybersecurity Infrastructure With increasing concerns around data privacy and security, medical device firms must prioritize the protection of proprietary data and digital systems. A proactive cybersecurity strategy is now a core component of risk management.
Foster Organizational Resilience Companies that invest in agility—whether through internal policy adjustments, workforce training, or operational decentralization—will be better equipped to handle uncertainty and change.
Turning Compliance into Competitive Advantage
Although the current climate introduces new challenges, it also creates an opportunity for medical device companies to lead with transparency, accountability, and strategic foresight. By aligning early with expected regulations and adopting resilient practices, organizations can position themselves as trusted partners in a more complex global marketplace.
As an ASCA certified FDA lab, F2 Labs is expertly positioned to assist medical device manufacturers in their regulatory needs to get their devices to market. Reach out to us today to help craft a regulatory pathway for your particular device.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
* Until August 15th, if you mention this blog post we will offer special pricing (20% off) your full REACH and RoHS evaluation with F2 Labs. *
We evaluate your device and keep it on autopilot, painlessly.
The RoHS Directive 2011/65/EU+(EU)2015/863 started life in 2002 as the RoHS Directive 2002/95/EC. It has changed over the years, adding substances and exemptions, and all affect the compliance of your device. Likewise, manufacturers and suppliers often change both the components and materials that comprise the parts you buy from them. And they do this with no obligation to alert you.
The REACH Regulation (EC) No 1907/2006 changes every six months. ECHA always adds substances to the restricted list. They never remove substances from the list which can make it excruciating for you and your staff. Presently there are 250 substances of very high concern, also called SVHC’s. That list is here: ECHA SVHC List and it will change again in either December 2025 or January 2026. Testing for REACH and RoHS is very expensive and it can cost thousands of dollars per part, depending upon what it is and how many materials make up the part. For example, a part made with plastic and metal can easily cost $3,000 to test. Just for one part. Now, multiply that against the number of parts a manufacturer like Molex, Murata, Vishay, or TE Connectivity produces. It is easy to see that this is a monumental task for these companies that never ends. You can imagine that once they clear a “list” of SVHC’s… right around the corner another, new list is published and the testing starts all over again. Then, add in that these companies likely have their own supply challenges and it is apparent that the RoHS and REACH status of these parts changes constantly.
What happens if the composition of a part changes?
Manufacturers can change how they make their parts. Suppliers can change who they buy a part from. In both cases they are not obligated to indicate to you, the electronic device manufacturer, what changes they made. In a worst-case example a supplier can sell you a machine screw made of RoHS and REACH compliant steel and use a descriptor and part number for that screw that is unique to their system. Let’s call it, “10 mm screw, pn 123456”. You could make orders for that screw over the years, always ordering their part number 123456, without knowing if that supplier is still using the same screw that was originally evaluated for RoHS and REACH compliance.
I routinely see examples of parts that were compliant at one point in time and then are not-compliant the next time the part is used in a build under review, and vice-versa. When this happens I see the part used in the new build — but I also see that the part is used in a build by a customer that submitted the device for review in the past.
Why is this important to you?
There is no one obligated at these companies to go through your past orders and tell you if a part you ordered a year ago now maintains the same RoHS and REACH status when you make a repeat order. You need to do this and it is your responsibility to alter your build(s) and or product documentation if there are restricted substances added into any of the parts used in your machine. No matter how insignificant. Even product labels made out of paper are in scope.
How can F2 Labs help you with this?
F2 Labs is a product safety and EMC test laboratory and we assist our clients with nearly all compliance requirements for global marketing and sales. We started offering RoHS services in 2014 and added REACH a few years later. We started these services because they are legal requirements and oftentimes our customers’ customer in the EU is unaware of these laws. We load your device in our system and can maintain the integrity of the build in an ongoing basis for products you make over and over. We can also perform a one-time RoHS and REACH evaluation for a custom product you are only making once.
Machinery, control panels, and medical devices are not excluded. RoHS and REACH apply to all equipment with electric function and that includes commercial, industrial, and medical equipment. REACH also applies to non-electric products. They are not restricted to consumer goods.
F2 Labs tracks down the EU RoHS and EU REACH (and we can do this for California Prop 65 and California RoHS also) status of each and every part, terminating with a report to you that indicates the compliance status. We can also tell you which of your suppliers responded and when, who ignored the request if that happens, and most importantly – the parts that are not compliant. The EU included teeth in these laws. They can fine you per device, make you pull it from the market, or even test it in the EU and then send the bill to you. You do not want to ignore these requirements, even if your customer in the EU did not mention them.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket testing to overseas labs.
“The FDA has no room for bad actors,” said Commissioner Marty Makary, M.D., M.P.H. “False and shoddy activity jeopardizes patient access, product sponsors, and the device supply chain.”
What Happened?
After detailed inspections, the FDA found both labs—used for U.S. device submissions—violated Good Laboratory Practices (GLP) and failed to ensure test reliability. Read the news releasehere
Key Violations Identified:
Data Integrity Failures: Incomplete, inaccurate, or untraceable test records
Weak Quality Oversight: Lack of QA systems and supervision
Animal Welfare Lapses: Poor documentation and animal tracking in biocompatibility studies
Training Gaps: Unqualified personnel performing critical testing tasks
These issues compromise the credibility of data submitted in FDA filings—posing risks to manufacturers and patients alike.
Implications for Manufacturers
The FDA reminds manufacturers that they remain fully responsible for the integrity of the data they’re submitting. Companies relying on these “bad actors” could face submission rejections or re-testing requirements. To mitigate risk, the FDA urges manufacturers to:
Reevaluate submissions tied to the cited labs
Strengthen due diligence when selecting third-party labs
Ensure traceability of all submitted test results
Use FDA ASCA-accredited laboratories whenever possible
If your compliance testing has gone off track, don’t worry—we’re here to support you. Let us help you bring clarity and direction back to your project in the fastest, most cost-effective way possible. We understand that time is money.
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So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business.
Brace Yourselves: The EU Is Mandating Cyber Hygiene for Wireless Devices
Starting August 1, 2025, the EU is tightening the screws on anything with an antenna or IP address. If your device transmits via radio and talks to the internet—even once—it now falls under the revised Radio Equipment Directive (RED 2014/53/EU). In short: your hardware just got a cybersecurity to-do list.
Yes, this applies to a wide array of products: routers, wearables, smart toys, baby monitors, fitness trackers, and any IoT thingamajig you’ve designed to be “smart.” Now it also has to be “secure.”
What’s In Scope?
If it’s radio-equipped and internet-connected, it’s in. Think:
Smartphones, tablets, wireless cameras
Routers and modems
Sensors, wearables, home automation gadgets
Basically, anything with Wi-Fi, LTE, Bluetooth, Zigbee, etc.
If it sends packets or listens for them, you should assume RED applies.
The Three Cyber Must-Haves
Here’s what the Directive now explicitly requires at the engineering level:
Devices that facilitate payments or virtual currency? You’re now responsible for:
Secure user authentication (multi-factor, biometrics, hardware tokens, etc.)
Transaction verification layers
Anti-spoofing and tamper resistance
No hardcoded secrets or reused cryptographic keys, please
This especially applies to mobile wallets, NFC payment gadgets, and wearables that act like debit cards.
But Wait—Where Are the Standards?
Here’s the fun part: no harmonized standards yet. That’s right. As of now, there’s no pre-approved checklist to mark as “compliant.”
You’ll likely need a Notified Body to evaluate compliance unless your implementation clearly aligns with best practices from:
ETSI EN 303 645 (IoT security baseline)
IEC 62433-1 (embedded system threat mitigation)
Translation: Just being “secure” won’t cut it unless you can prove it.
Non-Compliant? No CE Mark = No EU Market
If your product doesn’t meet these new cybersecurity requirements, forget about affixing that CE mark. Customs will be scanning for this, and regulators are expected to ramp up enforcement.
No CE = No sales in the EU. Period.
Engineering Teams:
Audit your devices now for radio+internet exposure
Revisit firmware and protocol stack designs with RED compliance in mind
Document your security measures—you’ll need the paperwork
Build with security as a core requirement, not a post-hoc patch
EU’s message to engineers: If you’re connecting it, you’re protecting it.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
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ECHA assessed the risks and found that Cr(Vi) is the most potent workplace carcinogen. People living near industrial sites are also at risk for lung and intestinal cancer. Cr(Vi) substances in the following use categories will be banned when they meet the defined limits for exposure and emission.
Formulation of mixtures
Electroplating on plastic substrate
Electroplating on metal substrate
Use of primers and slurries
Other surface treatment
Functional additives/process aids
Cr(Vi) substances are used in industries such as electroplating, surface treatment, aviation, and defense. A large number of authorization applications have strained regulators. ECHA is tasked with potentially transferring these substances from the Registration, Evaluation, Authorization, and Restriction of Hazardous Chemicals (REACH) list to the Restrictions List to shift focus from controlled authorizations to bans with limited exemptions.
This restriction could replace current requirements under the REACH. The REACH list now contains 247 hazardous substances and ensures protection for human health and the environment from hazardous chemical substances. Cr(VI) compounds were added to the REACH SVHC list in December 2010.
An 18-month transition period is being proposed for all restricted uses. ECHA can start a restriction procedure when it is concerned that a specific substance poses an unacceptable risk to human health or the environment. ECHA’s Committee for Risk Assessment will give opinions on whether the restriction is appropriate in reducing the risk to human health and the environment. If the European Commission approves, the restriction will be adopted, and the industry, including all manufacturers, importers, distributors, downstream users, and retailers, must comply. This means that instead of requiring prior authorization Cr(Vi) compounds would be banned from use in the EU.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
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Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates.
The warning explains that voluntary certificates issued by certification bodies not designated as notified bodies under EU law are misleadingly presented for products subject to EU harmonization legislation. A notified body is an organization designated with special credentials by one or more countries in the EU to assess the conformity of products before they are placed on the market. In most cases (almost all) you do not need a Notified Body.
These certificates are not recognized as proof of compliance. Only notified bodies can issue EU type-examination certificates for products and only for product types for which they are listed under NANDO (New Approach Notified and Designated Organizations). Harmonized standards demonstrate that products, services, or processes comply with EU legislation.
Some third-party certifications are misleadingly labeled with terms like “certification” or “certificate,” like the certificate example included below. They are labeled with a CE marking but in this context the CE marking is meaningless.
A device cannot carry a CE marking if it does not meet the requirements of the RoHS directive. RoHS is one of the legal directives a product must conform to bear the CE marking.
The guidance on the referenced European Commission sites indicates that the EU is cracking down on these. The certificate below holds no legal weight, every CE marking Directive requires, with no exceptions, an EU declaration of conformity to be available with the product if the product warrants a CE marking. No EU declaration of conformity, no CE marking. There is no half-measure.
Certificates like these can be deceptive. They look legitimate but are invalid as pertains any claim of CE marking compliance and could potentially stop your product in customs or by market surveillance authorities. The European Commission is clear about these documents; these “certificates” are not recognized as proof of compliance.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
“My machine is industrial machinery, do I have to comply with RoHS for CE marking?” We are frequently asked this question. The answer is – yes, unless you fall into one of the exclusions available from the RoHS Directive 2011/65/EU. We will pull this apart in this following article.
Let’s take it from the top. The RoHS Directive 2011/65/EU is for the Restriction of Hazardous Substances… colloquially known as “RoHS”. Pronounced “Ross” or “ROH-hass”. The RoHS Directive applies to anything with any electric or electronic function.
First, let’s define what is in scope and then we will look at the exclusions. RoHS is applicable per Article 2, 1:
This Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.
See the list from Annex I:
Large household appliances.
Small household appliances.
IT and telecommunications equipment.
Consumer equipment.
Lighting equipment.
Electrical and electronic tools.
Toys, leisure and sports equipment.
Medical devices.
Monitoring and control instruments including industrial monitoring and control instruments.
Automatic dispensers.
Other EEE not covered by any of the categories above.
Then – let’s see what “EEE” means. See the definition in Article 3, (1):
‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;
Summary – if your equipment has any electric or electronic function and it matches any of the equipment listed in Annex I… you are in scope and must comply with the RoHS Directive. This means that every single part of your build must meet the substance level restrictions indicated in Annex II (Note: Annex II was updated by Commission Delegated Directive (EU) 2015/863):
‘ANNEX II Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials Lead (0,1 %) Mercury (0,1 %) Cadmium (0,01 %) Hexavalent chromium (0,1 %) Polybrominated biphenyls (PBB) (0,1 %) Polybrominated diphenyl ethers (PBDE) (0,1 %) Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %) Butyl benzyl phthalate (BBP) (0,1 %) Dibutyl phthalate (DBP) (0,1 %) Diisobutyl phthalate (DIBP) (0,1 %)…’
The machinery above is in scope of RoHS, unless we can fit it into an exclusion. For the purposes of this article, assume it is in scope. What this means for this build is that every single part and every single piece of every part must comply with the substance restrictions identified in Annex II above. This means the blue and orange plastic, the screws, the cutting blade, housing, tool head, and every piece inside the housing (the board and all of its components) must individually comply with the restriction levels for the above ten identified substances.
Next, we will look at the exclusions dealing with large equipment. Depending upon your equipment – you may or may not be able to exclude it as ‘large-scale”. It depends on a few factors, including how large your equipment is and how large the final installation to which it will be fitted is, and how ‘custom’ your build is.
See RoHS 2011/65/EU, Article 2, 4., (c), (d), and (E):
This Directive does not apply to:
(c) equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment; (d) large-scale stationary industrial tools; (e) large-scale fixed installations;
OK, first let’s key in on (d) and (e) and what they really mean. See the definitions in Article 3, (3) and (4):
3) ‘large-scale stationary industrial tools’ means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;
(4) ‘large-scale fixed installation’ means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;
Next we see consider the two above definitions against Article 2, 4., (c) – defined above and summarized as equipment specifically designed for and permanently mounted to an excluded category of equipment… like large-scale stationary industrial tools and large-scale fixed installations. This does not mean that you can exclude your small device if it can be fitted to any large scale equipment. It means it can be excluded if your small device is custom made for a specific application (one machine, meaning… one unit) that is also excluded. If you make a thermostat that can be fitted to different HVAC systems you are unable to use the Article 2, 4., (c) exclusion. But, if you custom design a thermostat for a very large HVAC system that is custom made for a building or factory… and it is only made for that particular installation then, yes, it can be excluded.
But, what about larger equipment? The European Commission published very specific guidance about this in 2012 and it is still the reference material. That guidance is available at the Euorpean Commission’s RoHS page, here.
Download the FAQ at the link. The document you want is on that web page as a direct download link indicated by the green arrow above. The entire document is worth reading but for this article we want to look at the specific guidance in Section 3. Scope – Large-scale Exclusions starting on page 9. Section 3 elaborates on criteria for large-scale exclusions on page 11, see below:
One possible way of introducing a direct size criterion relates to transportation. The following guidance metrics and qualitative criteria can be applied for installations. If the installation exceeds the minimum requirements for one of the following criteria, it can be considered large-scale:
If, when installing or de-installing the installation, it is too large to be moved in an ISO 20 foot container because the total sum of its parts as transported is larger than 5,71m x 2,35m x 2,39m, it can be considered large-scale.
The maximum weight of many road trucks is 44 tonnes. Thus if, when installing or de-installing the installation, it is too heavy to be moved by a 44 tonne road truck, because the total sum of its parts as transported weighs more than the truck’s load capacity, it can be considered large-scale.
If heavy-duty cranes are needed for installation or de-installation, the installation can be considered large-scale.
An installation that does not fit within a normal industrial environment, without the environment needing structural modification, can be considered large-scale. Examples for modifications are modified access areas, strengthened foundations etc.
If an installation has a rated power greater than 375 kW, it can be considered large-scale. This is only an indicative list.
If your equipment can fit in one tractor trailer load then it is in scope. If your equipment can fit in a 20-foot ISO container it also is in scope. See the truck below. Can your device fit in it when it is crated up? You are in scope and must comply if the answer is yes. In fact, just placing a CE marking on your machine is a claim of compliance to RoHS, if it is in scope. There are penalties for non-compliance. In the case of RoHS especially, compliance is much less expensive than the penalties. In almost all RoHS projects at F2 Labs we are able to get through the evaluation with a positive conclusion (compliant EN 63000:2018 report) and without testing.
Finally, see also Q6.3 from the linked RoHS guidance document below:
Q6.3 Does RoHS 2 apply to EEE for professional and industrial use? Yes. RoHS 2, just as RoHS 1, does not distinguish between EEE for consumer use and EEE for professional and industrial use. In some cases however specific exclusions (Article 2(4)) or timelines (Article 4(3), 4(4) and 4(5)) may apply.
Our advice is that if you cannot exclude your equipment per the above, you are in scope.
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
Ah, the thrilling world of electromagnetic compatibility (EMC) testing! If you’ve ever dreamed of spending quality time with spectrum analyzers and line impedance stabilization networks (LISNs), you’re in for a treat. Let’s embark on a whimsical journey through the essentials of pre-compliance testing for your AC-powered gadgets or DC-powered gadgets that get that power from an AC/DC power supply, inspired by the wisdom of seasoned EMC professionals.
Setting the Stage: Your Test Setup
Picture this: your device under test (DUT) is lounging on a non-conductive table, probably contemplating its existence. Nearby, a spectrum analyzer eagerly awaits, ready to unveil the secrets of your device’s emissions. The LISN stands guard, ensuring that the power line impedance behaves itself. And let’s not forget the ground plane—whether it’s a fancy metallic sheet or a humble piece of heavy-duty aluminum foil, it’s there to catch any stray noise currents trying to escape.
The Usual Suspects: Common Mode and Differential Mode Noise
In the EMC detective story, two culprits often emerge: common mode (CM) and differential mode (DM) noise. CM noise is like that uninvited party guest who sneaks out through both the line and neutral wires, while DM noise is the bickering between the two wires themselves. Identifying which one is causing trouble is crucial for applying the right noise suppression tactics.
The Plot Thickens: Filtering Out the Noise
Without any filters, your DUT might be broadcasting its own radio station, much to the dismay of EMC standards. Introducing a filter board can act like a charm school, teaching those unruly emissions some manners. For instance, adding a filter designed for 150 kHz to 30 MHz can reduce noise by an average of 10 dB. But why stop there? Throwing in a pair of 100 µH inductors in series can further discipline those emissions, achieving reductions up to 30 dB. It’s like sending your emissions to a strict boarding school—they’ll come back transformed.
The Grand Finale: Why Bother with Pre-Compliance Testing?
Embarking on pre-compliance testing is like rehearsing before the big performance. It allows you to catch those off-key notes early, saving you from embarrassing failures during the official compliance test. Plus, it saves time and money—two things every engineer loves. So, embrace the process, and may your devices pass with flying colors (or at least within acceptable emission limits).
Remember, EMC testing doesn’t have to be a dry, monotonous task. With a bit of humor and the right approach, you can turn it into an electrifying adventure. Happy testing!
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