F2 Labs’ is Officially Approved as an FDA ASCA-Accredited Testing Lab!

We are excited to announce that F2 Labs is officially an ASCA-accredited testing laboratory! We are one of only 17 labs approved by the FDA for this groundbreaking certification.

As an ASCA-accredited laboratory, we are certified to perform testing in accordance with the specifications of ISO/IEC 17025 and ASCA program specifications. This program will help increase product safety for the end-user and shorten the time it takes for FDA approval of your product.

What is ASCA?

The FDA launched ASCA to support its public health mission by increasing confidence in test results provided by testing laboratories. Becoming accredited comes with standards a laboratory must follow beyond the initial application process, including periodic audits. This helps ensure confidence with the FDA that we follow the proper procedures and help get your product through the FDA 510K process quicker.

The ASCA program will NOT introduce new requirements for medical device manufacturers. Instead, the ASCA intends to promote consistency and predictability in all of the FDA’s premarket submission programs.

When a lab is ASCA accredited, medical device manufacturers can be more confident that the lab conducting testing (within the laboratory’s scope of ASCA Accreditation) is likely to meet FDA’s regulatory requirements. Your products are no longer likely to be excluded from FDA approval because of an issue related to the lab’s testing if you use an ASCA Accredited lab in good standing.

The FDA believes the experience gained in the ASCA Pilot could broadly inform international harmonization efforts such as standards use across jurisdictions. ASCA is designed to increase manufacturer and consumer confidence in medical device testing, which will help ensure the widespread accessibility of safe and effective medical devices.

F2 Labs can provide more detail about the ASCA program as it relates to your product. You can also find more information and helpful resources at F2Labs.com. The ASCA program and F2 Labs’ accreditation through it, helps us fulfill our mission of partnering with our clients to make the world a safer place.

Please feel free to contact us if you have any questions.

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The FDA’s ASCA Program

Big news in the product compliance world is the FDA’s new ASCA program. The FDA has launched ASCA with the intention to support its public health mission by increasing confidence in test results provided by testing laboratories. Testing laboratories apply to become ASCA-accredited. This is the first time in history that the FDA has had a list of approved labs. Becoming accredited comes with standards a laboratory must follow past the initial application process, including periodic audits that can result in suspension or withdraw of accreditation.  

The FDA hopes this program will help enhance confidence in medical device testing, promote consistency and predictability in the premarket review process, encourage effective use of FDA resources, and support international harmonization. The increased confidence in testing may be particularly helpful for premarket submissions that rely on Declarations of Conformity to FDA-recognized consensus standards using test results from ASCA-accredited testing laboratories.

ASCA does not introduce new requirements for medical device manufacturers. Rather, by clearly communicating expectations for how results from ASCA-accredited testing laboratories are included and reviewed in premarket submissions, the ASCA intends to promote consistency and predictability in all of the FDA’s premarket submission programs.

By virtue of a testing laboratory’s ASCA Accreditation, device manufacturers can be more confident early in the product development lifecycle that testing to the FDA recognized consensus standards and test methods within the laboratory’s scope of ASCA Accreditation is likely to meet FDA’s regulatory requirements.

FDA used elements from international conformity assessment standards in the ISO/IEC 17000 series to establish the ASCA Pilot. The standards within the ISO/IEC 17000 series are used worldwide by stakeholders including accreditation bodies, testing laboratories, and device manufacturers. In addition, most of the FDA-recognized consensus standards and test methods selected for the ASCA Pilot are international consensus standards. FDA believes the experience gained in the ASCA Pilot could broadly inform international harmonization efforts such as standards use across jurisdictions.

ASCA is designed to increase confidence in medical device testing (by both manufacturers and consumers), which in turn will help to ensure the widespread accessibility of safe and effective medical devices.

F2 Labs is officially an ASCA-accredited testing laboratory that performs testing in accordance with the specifications of ISO/IEC 17025 and FDA ASCA program specifications. We believe this program will help not only increase product safety for the end-user but also shorten the time it takes for FDA approval of your product. Let F2 Labs provide you with the testing you need to get through the FDA approval process.

For more info from the FDA about the ASCA program, click here.

To schedule testing for your product contact us or call 877-405-1580.

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UKCA Mark

The UK has left the EU and new rules concerning the transition for most CE products to UKCA products began in January 2021. The transition period for most products ends on December 31, 2021.  All products shipped into the UK after that date must have the UKCA mark and a UKCA Declaration of Conformity.

About the UKCA Mark

The UKCA (UK Conformity Assessed) marking is the new UK product marking used for goods that hope to be placed on the market in Great Britain. In most cases, these goods previously required CE marking.

F2 Labs recommends that you contact us as soon as possible to ensure your product will meet the deadline for this transition.

Even though the technical requirements and conformity assessment process and standards that demonstrate conformity for both the UKCA and CE markings are largely the same, the UKCA marking is not recognized in the EU market and the CE mark will not be recognized in the UK market (at the end of the 2021 transition period).

If your product is not already CE Marked, testing would need to be conducted so that the CE and/or UKCA mark can be applied to the product.

Manufacturers can supply a UKCA Declaration of Conformity beginning on January 1st, 2021. However, it will not be mandatory until the end of the implementation period, which is December 31st, 2021 (with some exceptions).

Product Labeling, Technical Documentation, and Declaration of Conformity with UKCA

Product labeling is required for UKCA products in the UK market. In most cases, you must apply the UKCA marking on the product itself or the packaging. Starting in January 2023 the label must be permanently attached unless otherwise specified in legislation.

Technical documentation that demonstrates your product’s conformity with regulatory requirements must be kept for up to 10 years after the product is placed on the market. Product documentation can be requested at any time by market surveillance or enforcement authorities, for the safety of the public. The information requested will vary depending on specific legislation pertaining to your product.

A Declaration of Conformity must be supplied to the end-user for most products with a UKCA mark. The declaration of conformity declares key information about the product, including your name and full business address and the product’s serial number, model, or type identification, etc.

Similar to the technical documentation, the declaration of conformity should be available to market surveillance authorities on request.

For more detailed information, check out our main UKCA page or contact one of our representatives.

Products covered by the UKCA Marking

  • Toy safety
  • Recreational craft and personal watercraft
  • Simple pressure vessels
  • Electromagnetic compatibility
  • Non-automatic weighing instruments
  • Measuring instruments
  • Lifts
  • ATEX
  • Radio equipment
  • Pressure equipment
  • Personal protective equipment
  • Gas appliances
  • Machinery
  • Equipment for use outdoors
  • Ecodesign
  • Aerosols
  • Low voltage electrical equipment
  • Restriction of hazardous substances
  • medical devices*
  • rail interoperability*
  • construction products*
  • civil explosives*

*covered by UKCA marking but have special rules.

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UKCA mark and CE marking – September 2020 update from F2 Labs

We published an article about Brexit and its implications for CE marking back in February of this year. A link to that article is here. The UK government posted new guidance about this on September 1, 2020. The link to that information is here.

You do not need to go to those links and sift through the information. We have summarized the main points below.

  • CE marking will apply to most products until January 1, 2022. These product area categories are:
    • Toys
    • Recreational and personal watercraft
    • Simple Pressure Vessels
    • EMC
    • Non-automatic Weighing Instruments
    • Measuring Instruments
    • Lifts
    • Radio Equipment
    • Pressure Equipment
    • Personal Protective Equipment
    • Gas Appliances
    • Machinery
    • Outdoor Noise
    • Ecodesign
    • Aerosols
  • CE marking will apply to medical devices until June 30, 2023.
    • Note that beginning January 1, 2021 all medical devices and in vitro diagnostic medical devices imported into the UK must be registered with the Medicines & Healthcare Products Regulatory Agency.
    • There is a 4-month grace period for Class IIIs, Class IIb implantable products, and active implantable medical devices
    • There is an 8-month grace period for registering for Class IIb and Class IIa devices.
    • All manufacturers based outside the UK will need to establish a UK Responsible Person.
    • There is a 12-month grace period for Class I devices.
    • You can start using the UKCA mark (if your product complies) as soon as January 1, 2021 but if it is a medical device the CE marking will suffice until June 30, 2023.

You will need to apply the UKCA mark to your product beginning January 1, 2021 if all of the following apply to the product:

  • it is for the market in Great Britain, and
  • it is covered by legislation which requires the UKCA marking, and
  • it requires mandatory third-party conformity assessment, and
  • conformity assessment has been carried out by a UK conformity assessment body and you haven’t transferred your conformity assessment files from your UK body to an EU recognised body before 1 January 2021. *Note that most UK bodies have opened offices in the EU.

The above means that if your product is a medical device you will need to register it in the UK at the end of this year or sometime in 2021 based on device category. You will also need a UK Responsible Person. Regarding other product categories you have some time (another year) as long as your product does not meet all four bulleted points immediately above.

We can be contacted via this link

We can be reached by phone at 877-405-1580 and are here to help you. 

F2 Labs is here to help.

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F2 Labs customer receives US FDA approval for a device used in the battle against COVID-19

The Circadia C100 Remote Bedside Monitor paired with the Circadia Pro App helps nurses monitor multiple patients at one time.

It is safe to say that COVID-19 has affected everyone in the world. F2 labs immediately joined the fight and offered pro-bono services to our customers who are working to alleviate the suffering caused by this terrible illness.

“It was the right thing to do and, I am so proud of everyone on our team who worked to get these evaluations completed quickly and correctly,” is how Wendy Fuster, President of F2 Labs, characterized the effort.

One of our customers, Circadia Health, worked with F2 Labs in pursuit of FDA 510(k) clearance on a bedside device for monitoring the breathing of people stricken with the disease and to help with early detection.

Our engineers knew that this wasn’t just a project: it was a way for us to “get in the fight.”

This device is so significant that it was featured in today’s Wall Street Journal.

The Circadia C100 was evaluated at F2 Labs EMC and Safety testing laboratories.

We can be contacted via this link

We can be reached by phone at 877-405-1580 and are here to help you. 

F2 Labs is here to help.

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RoHS 2011/65/EU and (EU)2015/863 – What is the difference?

Understanding the requirements for compliance to RoHS 2011/65/EU is not difficult (and we can help you), but ignoring them can get your product stopped upon entry into the EU.

RoHS stands for the “restriction of hazardous substances”. Initially, it restricted four heavy metals and two flame retardants per Annex II.

Compliance with the RoHS Directive 2011/65/EU is required for categories of electrical and electronic equipment which are indicated in Annex I.

The Annex II list is very comprehensive. Basically, any equipment that has any electric function is in the scope of this Directive. Equipment that is in the scope of RoHS must meet all of the substance restriction levels in Annex I. More specifically it means that every single part in your product (every pin, every resistor, every screw, even labels, and paint) must also individually meet those substance restriction levels. You cannot use a small part which is composed of 5% lead and compare that part in the context of the weight of the whole device. Each part must also be compliant.

The EU has published many amendments to the RoHS Directive. Most deal with very specific exemptions that are industry or application-specific. For instance – brass and other copper alloys can have a lead content of up to 4%. The EU publishes these in the Official Journal of the EU and also on a RoHS web page that is constantly updated. That page is here.

Below is a screenshot of the RoHS page with links to RoHS 2011/65/EU and all of the published amendments.

Notice that there are many, many amendments – but only (EU)2015/863 and (EU)2017/2102 are separated from the main list. (EU)2017/2102 is a short document that clarifies some language and addresses the use of spare parts and pipe organs (yes, pipe organs). (EU)2015/863 is much more important because it added four new substances to the Annex II list above: four phthalates. Phthalates, I have learned, are plasticizers that make plastic more pliable. Googling it, I came to a CDC fact sheet defining them in greater detail.

Therefore the importance of (EU)2015/863 is contained in the expansion of Annex II in RoHS 2011/65/EU. See below.

The last four substances are the “new” restricted phthalates. Now that I have laid the groundwork, we have arrived at the main purpose of this article:

Claiming compliance to RoHS 2011/65/EU encompasses a claim of compliance to (EU)2015/863 also as long as the original six-substance list is not referenced.

I wrote that in bold and italics because many times I see reference to “RoHS3” or “RoHS 2015/863.” Because of the confusion surrounding this, we write it as “RoHS 2011/65/EU + (EU)2015/863” on our proposals and much of our correspondence with our customers.

I have referenced the EU’s RAPEX weekly reports many times in the history of this blog. Click that link and subscribe if you are involved in the export of equipment and products to the EU. Every Friday, you will receive an email with a list of products that are stopped in EU customs. Not all products that are stopped – just what they consider to be especially hazardous.

Today I opened the link in my email and reviewed a couple of products that were stopped for non-compliance to RoHS. See below.

Both of those images open to the corresponding alerts. I want to draw your attention to two things:

  1. RoHS 2 is referenced. This means RoHS 2011/65/EU. Remember: that also means Commission Delegated Directive (EU)2015/863.
  2. Both products were stopped because the welds contained excessive lead. They did not note that the whole product has a higher than acceptable level of lead: just the welds.

If I had to guess, based on my experience in handling RoHS compliance for F2 Labs customers since 2014, I would bet that the products did not claim any compliance to RoHS at all, or had a weak claim (no report to EN 50581:2012 to back it up).

Is the picture at the bottom of this article what comes to mind when you think about RoHS? Don’t. We have handled hundreds of RoHS compliance projects for our customers. The first step we take is to determine if we can exclude it. (Yes, there are some exclusions!). We can help you too.

We can be contacted via this link. We can be reached by phone at 877-405-1580
and are here to help you. 

F2 Labs is here to help.

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NOTICE: We are offering PRO-BONO services – Can we help you?

If you are producing a product that can help with this crisis and you’re in need of assistance with regulatory approvals, advice, guidance or testing, we are here and want to do our part to help the country during this time of need.

Please call us.
In the wake of the Coronavirus, COVID-19, pandemic, we want you to know we care about you and we hope that you, your colleagues, family members, and friends are healthy and safe. 

F2 Labs is taking all precautions to keep our employees and customers safe and we are open for business. We are fully committed to being here when our customers need us.

Our staff is continuing to focus on providing the highest level of customer service.
We can be contacted via this link. We can be reached by phone at 877-405-1580
and are here to help you.
F2 Labs is here to help.
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My product recharges or powers from a USB cable, do I need to comply with the Low Voltage Directive 2014/35/EU?

The question in the title of this blog article is frequently asked by our customers.

Let’s break it down.

See the LVD 2014/35/EU, Article 1, para 2:

The Low Voltage Directive 2014/35/EU applies to products with a power input of 50 to 1,000 VAC and to products with a power input of 75 to 1,500 VDC. So, a product with a port for a mini-USB or a USB cable runs or charges from a 5 VDC input. It is excluded, right?

Maybe. Maybe not.

There are some distinctions. Technically, if you supply your small toothpick dispenser (my favorite widget example) to the EU…

  • and it only has a port for USB and that port is labeled “5 VDC”…
  • and your manual says that it requires 5 VDC…
  • and there is no mention of any connection to AC mains power (plugging into the wall) then your product is excluded from the Low Voltage Directive 2014/35/EU.

The EU authorities can and will look at your marketing literature, the packaging, the manual, and your website. They can say that your product is AC mains powered (in the EU that would be 220-230 VAC) if they see anything that shows your product plugged into the wall.

Let’s face it: a USB port on your product means that someone will likely take that product and connect a USB cable to it and then to a USB wall charger. Like the kind that come with every iPhone. In that case it is AC mains powered.

Here are some rules of thumb:

  1. Supplying a charger or AC/DC power supply with your product makes it instantly in the scope of the Low Voltage Directive.
  2. Specifying a connection to an AC/DC power supply for use with your product makes it instantly in the scope of the Low Voltage Directive.
  3. A marketing picture showing this product connected to a wall charger makes it instantly in the scope of the Low Voltage Directive.

I often refer to the EU’s RAPEX weekly reports in this blog because it is a very useful tool to understand why products are stopped in customs and / or pulled from shelves. Below are some examples that illustrate the above. Clicking the pictures takes you to the individual alerts with more detail.

Below is a hover-board. Clearly not intended to operate while plugged in and charging.


.

Next up is a rechargeable electric razor.

Below is a rechargeable LED light for use while camping.

And below is a final example. Keep in mind that I searched “electric shock” as the risk on the RAPEX page and only for 2020 and 2019. There were more than 30 pages (with multiple entries per page) and I only went through the first few pages.

This final example is a solar powered light.

Notice that this light is supplied with a USB port and the authorities indicate non-compliance with the Low Voltage Directive and the following in the alert: A black and white rechargeable, portable table / wall LED lamp with a USB port, which can be operated directly from the mains, batteries or by the built-in solar module. The product is supplied with a charger and packed in a cardboard box.

The sales and engineering staff at F2 Labs study these issues every day. Call us. We can help you take an educated compliance path for your product.

We can be contacted via this link. We can be reached by phone at 877-405-1580
and are here to help you.

F2 Labs is here to help.

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RoHS 2011/65/EU + (EU)2015/863 and EU custom’s enforcement the week ending February 28, 2020

I get an email from RAPEX every Friday morning that details products stopped in customs in the EU for various issues. These are not all of the of the products stopped, just the most dangerous ones. RAPEX is an acronym for Rapid Alert System for dangerous non-food products.

Last Friday, February 28, 2020 I opened the email in the morning, which sent me to this link, and started scrolling like I do every week. I immediately noted that there appeared to be a larger than normal number of products stopped for non-compliance to RoHS 2011/65/EU.

This link is one example of a product stopped for RoHS non-conformity: Link.

The RAPEX email and alert is meant to tell everyone in receipt that the subject products are dangerous and should be removed from use immediately. Of course you do not want to end up in one of these alerts!

F2 labs offers RoHS evaluations for EU (CE marking) compliance. Usually we make these evaluations based on a study of your supplied BoM and no testing for RoHS is required in most cases.

We can be contacted via this link. We can be reached by phone at 877-405-1580
and are here to help you.

F2 Labs is here to help.

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Why selecting the right power supply is crucial to EMC Testing Results

Most of our customers must comply with the EMC Directive 2014/30/EU prior to application of a CE marking to their products. This is because the EMC Directive is applicable to almost everything with active electronics. Unlike North American EMC compliance (FCC and ICES) which requires emissions compliance only, EU compliance to the EMC Directive requires emissions and immunity testing.

Proving this in most cases means testing to one or a pair of harmonized EN standards for EMC. These harmonized standards indicate the required tests – which are usually contained in other standards we call “test standards”. The most frequently used EMC test standards are below.

  • EN 61000-4-2 – ESD Immunity
  • EN 610004-3 – Radiated Immunity
  • EN 61000-4-4 – EFT Immunity
  • EN 61000-4-5 – Surge Immunity
  • EN 61000-4-6 – Conducted Immunity
  • EN 61000-4-8 – Magnetic Fields Immunity
  • EN 61000-4-11 – Voltage Dips/Interrupts
  • EN 55011 – Radiated and Conducted Emissions
  • EN 61000-3-2 – Harmonic Current Emissions
  • EN 61000-3-3 Flicker/Voltage Fluctuations Emissions

Now we come to the purpose of this article: power supplies and the problems that can be created for your compliance project if you select one that is not suitably approved. We frequently see documentation for power supplies that does not prove compliance. These power supplies can be the source of EMC testing failures in our chamber because power supplies can cause emission issues. And non-compliant power supplies cause more issues than compliant power supplies.

The documentation for a power supply may look, on its face, like the product is compliant but a little investigative work often shows that it is not. Keep in mind that anyone can place a CE marking on a product. Actually complying with the requirements is different. Because of this we suggest asking for the test report or reports from the manufacturer.

We have seen many reports that were generated by a manufacturer internally. In the world of compliance these are not valid. Why? To be an actual test report the testing lab must have laboratory accreditation and the gear used to test the products must be continually calibrated. That gear and the calibration dates must be listed in the report. The testing standard must also be listed in the report.

Our sales department can discuss these issues with you. In fact, our salespeople look at these documents so frequently that we can often immediately tell you if a test report or declaration of conformity appears valid.

I hope this helps. Please contact us today with any questions or to discuss your project.

877-405-1580

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