Navigating CE Compliance – A Case Study

Navigating CE Compliance for entry into the EU can be daunting at times, because of the sheer number of regulations and Directives that may apply to your given product.  Without the help of a trusted testing partner (seriously, contact us when you have a new product in development), it may be difficult to determine what you are legally required to comply with. 

Any product that is going to be placed on the marketplace in Europe must comply with all Directives that are applicable to said product.  In this blog post we’re going to look at a sample product to determine what Directives apply and what needs to be done. 

Product in question – Flatscreen computer monitor

Power – 220VAC via supplied charger – no battery backup

In this scenario we are working with a piece of equipment that I bet most of us have lying around our home.  Now counter to US/Canadian certification where you find an applicable standard and test to it, European (CE) compliance requires us to first determine which Directives apply to the product and THEN find an appropriate Harmonized Standard under the Directive to test to.

Let’s first look at the electrical safety of this device.  Any device that connects to mains power, whether for operation or for charging is required to comply with the Low Voltage Directive (LVD) (2006/95/EC).  Some folks may point to the fact that this device operates under 60VDC and thus may qualify for an exemption under the LVD, however since it uses an off the shelf AC/DC brick power supply that is powered via mains, it must comply with the LVD.  The applicable standard under the LVD would be:

EN 62368-1 – Audio/video, information and communication technology equipment – Part 1: Safety requirements

Now we must address the Electromagnetic Compatibility (EMC) of the device.  The device must be tested to ensure it doesn’t affect other electronics and is itself not affected by Electromagnetic phenomena such as surges, interrupts, ESD, etc.   The standards for this category are below:

EN 55032 – Electromagnetic compatibility of multimedia equipment – Emission requirements

EN 55035 – Electromagnetic compatibility of multimedia equipment – Immunity requirements

Now all electrical devices must comply with RoHS (Restriction of Hazardous Substances) (2011/65/EC).  It is a CE marking Directive and you must comply in order to CE mark your device.  This usually is an analysis of your BoM to ensure compliance.  RoHS changes very infrequently, having only been modified once since 2002. 

Finally, the portion that gives a lot of manufacturers trouble in today’s marketplace is REACH.  Even though it is not a CE marking Directive, every product that ships into the EU must comply with the REACH Regulation.  Again, this is an analysis of your BoM, but to fulfill these obligations, manufacturers and importers need to prepare a registration dossier in a specific format (IUCLID) and submit it to the European Chemicals Agency (ECHA) via the REACH-IT portal.  This Regulation changes about every six months, and you must ensure that you meet the most recent version anytime you are shipping to the EU.  F2 Labs offer a subscription based service where we will ensure your product remains in compliance with REACH as it updates and changes.

F2 Labs is a turnkey solution when it comes to EU compliance.  We can assist with all required testing to claim compliance to the associated Directives and we will even draft a Technical File template that will include a draft Declaration of Conformity.

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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Pacemakers and Electric Cars

Over the past decade, we have seen an explosion of popularity with various green technologies, and at the forefront of that are electric vehicles and the charging stations that keep them going.  A new study questioned whether individuals who wear pacemakers can safely operate an electric vehicle or use a high-power charging station.

The study, performed by the European Heart Rhythm Association (EHRA) in Barcelona, Spain, shows that yes, it is perfectly safe to use and operate these devices, assuming you don’t place the charging cable directly over your pacemaker or stay near the charger for an extended period.

“The new high power charging stations for electric cars have the potential to create strong electromagnetic fields and cause electromagnetic interference in pacemakers and defibrillators, leading them to malfunction,” said study author Carsten Lennerz, MD, of the German Heart Centre Munich. “We previously investigated the risk of electromagnetic interference with cardiac devices while driving electric cars and found that the largest electromagnetic field was located along the charging cable. This was the first study to examine the risk of electromagnetic interference in patients with cardiac implantable electronic devices (CIEDs) while using high power chargers.”

The study found that of the 561 total charges that participants were asked to perform as part of the program, no adverse events were caused by electromagnetic interference.  Specifically, there were no malfunctions of the pacemakers that would have inhibited their ability to detect arrhythmias.  

If you’re looking for safety and EMC evaluations for electric vehicle charging systems for any market, reach out to us right away. 

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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Helpful Guide if you are new to RoHS, REACH, WFD, & SCIP

Last June I had a discussion with an F2 Labs customer about the confusion of RoHS and REACH, and that she did not have time to become an expert on either of those two regulations. She contracts us to maintain the compliance of about 20 products for one international company. Because she is busy, and this is just one part of each project, she needs to know just enough about RoHS and REACH so that she can communicate to her colleagues what we need to evaluate the build for compliance.

While on the Teams call, I opened a word document and wrote in laymen’s terms what each of the two regulations are and how they affected her company and its products as we discussed each topic. After the call I decided to save this brief summary because this is an ongoing conversation with almost all of our customers. I have sent a pdf of the below to many customers ready to throw their hands up about RoHS and REACH. We can help you. We will show you that it takes 90 seconds to make a IUCLID submission. Then we will show you where your product will land, in the ECHA SCIP database.

See below –

I would write out a summary of the above… but the above is the summary. We will be happy to discuss your EU RoHS and REACH project – or any project for which you need assistance.

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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ESD for Electric Vehicles (EVs)

As electric vehicle (EV) technology continues to evolve and grow and become more commonplace, the insertion of ethernet technology for data communication in those systems will also continue to evolve. 

As with any electric function, but especially in the case of EVs, where the functions of the components/systems are critical to operation, ESD protection is extremely important.  Two standards were published in 2016, 100BASE-T1 and 1000BASE-T1, which were adopted to serve specific automotive requirements as it pertains to electromagnetic compatibility (EMC). 

IEEE 802.3bw and IEEE 802.3bp are also utilized to cover some of the ESD requirements, which include the robust +/- 15k V contact ESD discharge for unpowered devices with a minimum of 1000 discharges. 

F2 Labs can assist with the ESD testing that is required for electric vehicle and more.

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.

F2 Labs is here to help.

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WPT for EVs and the Effect on AM Radio Broadcasts

As more and more electric vehicles (EVs) continue to be utilized both by the public and by government agencies to help reduce our carbon footprint and reduce greenhouse emissions, the infrastructure used to power these vehicles continues to grow.

An un-welcome side effect of this, is that Wireless Power Transfer Systems (which relies on switching frequencies that generate interference in the AM radio bands), can interrupt AM radio broadcasts in several frequency ranges. 

EMI interference can be mitigated by using shieled cables, installing filters, and perhaps utilizing ferrite beads as required, however because of the nature of wireless charging technology (which transmits power through the air as a magnetic field), these mitigation efforts cannot be utilized.

If you are the manufacturer of equipment and need assistance with EMI/EMC testing for either wired or wireless platforms, reach out today.  F2 Labs can assist with many compliance needs for FCC, Industry Canada, as well as CE Mark evaluations

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.

F2 Labs is here to help.

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Use of UKCA Mark Postponed

On November 14, 2022 the UK announced that use of the UKCA Mark (for Great Britain) is to be postponed an additional two years until December 31, 2024.  Previously, mandatory use of the mark and scheme was supposed to be active as of January 1, 2023. 

Consequently, the CE Mark will continue to be accepted for most product categories, including product that fall under the UK Radio Equipment Regulations and UK EMC Regulations.

F2 Labs continues to be at the forefront of assisting clients worldwide gain acceptance and ensure proper conformity to applicable Directives, including Low Voltage Directive, Radio Equipment Directive, EMC Directive, Machinery Directive and ATEX Directive, amongst others.

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.

F2 Labs is here to help.

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Changes to KS C 9814-1 – EMC Updates

On May 31, 2022, a new version of KS C 9814-1 was issued and is applicable to products that fall in the category of household appliances, electric tools, and other similar apparatus.  Examples of equipment that fall in this category include air conditioners, personal and beauty care devices, electric fences energizers, and products that utilize IPT Technology, or Inductive Power Transfer Technology (devices that make it possible to transfer power and digital data without mechanical or electrical contact). 

KS C 9814:2022 is a modified version of CISPR 14-1:2020 and changes have been made to the previous edition, KS C 9814-1:2020(CISPR 14-1:2016).  The changes mainly have to do with increased emission requirements that deviate from the CISPR standard. 

Reach out to F2 Labs today if you have products that are entering South Korea and require EMC testing.  We are well equipped and accredited to assist you in this marketplace. 

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.

F2 Labs is here to help.

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Commission Implementing Regulation (EU) 2022/1426

In the emerging technology field of Automated Driving Systems (ADS), the European Union Commission has recently published requirements and rules to help manufacturers of these systems ensure the overall safety of automated vehicles.

European Union Regulation 2022/1426 was published in early August and over the course of four specific Annexes, details regulations and specifications that need to be followed in order to gain type-approval in the EU

These four Annexes detail:

  • The information needed to be supplied by ADS manufacturers in support of their type-approval request
  • Under various scenarios and conditions, the performance requirements and regulations specific to ADS are outlined
  • Expansive detail on the review process officials will use to assess and approve ADS for compliance, including scope of testing and reporting
  • Specific requirements that are to be followed in drafting supporting documentation and actual drafting of the type-approval certificate once compliant test data has been established

As this technology continues to emerge and take off, these regulations will most assuredly continue to evolve and test labs will continue to add to their capability to assist manufacturers of these products.

The regulation in it’s entirely can be found here.

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.

F2 Labs is here to help.

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Complying with REACH & RoHS – and the Need for Continued Review

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 224 substances of very high concern, also called SVHC’s. That list is here: ECHA SVHC List and it will change again in either December 2022 or January 2023. 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. Below is an example.

TE Connectivity part number 87224-2

This part, number 87224-2, from TE Connectivity has been used in a few different projects from different manufacturers, first appearing in our system in 2020. 87224-2 was originally made with a REACH SVHC called 1, 6, 7, 8, 9, 14, 15, 16, 17, 18, 18-Dodecachloropentacyclo [12.2.1.16,9.02,13.05,10] octadeca-7, 15-diene (“Dechlorane Plus”). See a screenshot below from the Statement of Compliance produced by TE Connectivity in September 2020:

However, when this part was added to another assembly under review it was researched again in 2021 and we uncovered that TE Connectivity changed the build. As of May 27, 2021 the sole SVHC was eliminated from the build:

87224-2 is a popular part and crept into yet another build under review at F2 Labs this month. Reviewing the current data, we see that it has maintained its status as devoid of SVHC content:

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.

F2 Labs is here to help.

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Installing New Pickups from Seymour Duncan

A benefit of working at F2 Labs is that I get to see new and innovative products, straight from the bench of the inventor, and prior to general release. One of our customers, Seymour Duncan, submitted a device for us to work on and I completed the RoHS portion of the project.

I looked at the product offerings on their site during the project and immediately became interested in the after-market pickups they make for guitars. My favorite guitar is the Fender Telecaster because of… well, everything about it. The Telecaster uses a type of pickup that is very articulate but is made from one coil, called a single coil. The result is that it transmits a lot of external ‘noise’ from the surrounding area, called common-mode noise. Things like computers and lighting around the guitar can add unwanted sounds, like loud static and humming. Seymour Duncan makes a replacement set of pickups that are a type of humbucker. Humbuckers are pickups made of two coils (instead of one) which cancel a lot of that humming sound because they are wired together out of phase.

Seymour Duncan Vintage Stack Tele Pickups

Instead of aligning the two rows of coils side by side, these pickups are ‘stacked’ one on top of the other. Hence the name, “Vintage Stack Tele“. The order was placed and within a few days I received these in the mail. Since I work in sales and consulting and not engineering at F2 Labs this seemed like it would be a daunting task. After talking with the Seymour Duncan personnel during our project I learned that it is not hard to do this – and was offered help if I ran into any problems. It turned out to be as easy as he said and all I needed was a $15 soldering iron and some solder.

The Installation!

Next, I took the pick cover from my guitar and, following the included instructions, disassembled the Fender OEM pickups. No turning back now.

Ready for the new pickups.

New, installed Seymour Duncan Vintage Stacks!

Yes, it was as easy as described.

I finished the install and looked at it (and still do) with great satisfaction. Kevin at Seymour Duncan gave me the ‘nudge’ I needed to do this. Thank you Seymour Duncan.

CONTACT F2 LABS FOR HELP WITH YOUR PRODUCT.

Want to discuss your project with us? (Sometimes we not only assist with the compliance part… we may become a customer also.)

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

F2 Labs is here to help.

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