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Recent Posts
- NFPA 790 vs. NFPA 791: A Field Evaluator’s Guide to This Dynamic Duo
- Why Does EMC Testing of a Medical Device to IEC 60601-1-2, AIM 7351731, and/or Common EM Emitters Testing Have to be Conducted in Both Charging and Battery Modes? (Even When the Device Is Basically Just Napping on the Charger)
- Is My Specially Designed Equipment in the Scope of RoHS?
- Why ISO/IEC 17025 Accreditation Matters for Electrical Safety & EMC Testing | F2 Labs
- We Offer CE Marking Training For Your Organization
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Category Archives: CE marking
CE Marking: Your Electronic Product’s Passport to Europe
If electrical products had passports, the CE mark would be their golden ticket to travel freely across Europe. But unlike that dusty old passport you forgot to renew, CE marking isn’t just a stamp—it’s a declaration of compliance with essential … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
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ECHA Adds Five New Substances to SVHC List
The European Chemical Agency, ECHA, added five new substances to the list of Substances of Very High Concern (SVHC) overnight. The EU’s SVHC list expanded from 242 to 247 today. These are potentially dangerous substances that carry EU reporting responsibilities … Continue reading
Posted in CE marking, Consulting, REACH, RoHS Directive 2011/65/EU
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Does Customs Really Check For RoHS in The EU?
Yes. I get an email every week from the European Commission’s Safety Gate that lists some of the most dangerous products that were recently pulled from the market. These alerts are for products stopped in customs before they enter the … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
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Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice
Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good … Continue reading
Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745
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IEC 60601-1-9 Environmentally Conscious Design – What is it?
What exactly is the environmentally conscious design file? You need documentation/policies that show how you are addressing the requirements of that standard. You really should use the standard as guidance (IEC 60601-1-9). Here is some good information on what this … Continue reading
Posted in CE marking, EN 60601-1, IEC 60601-1-9, Medical Devices Regulation (EU)2017/745
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Navigating CE Certification for Entry Into the European Market
As both established and startup consumer electronics manufacturers look to expand their market reach, the European Union presents an enticing, lucrative growth opportunity. Entry into this market comes with its prerequisites, however, one of which is CE certification testing. This … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
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The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?
The Machinery Regulation (EU)2023/1230 was published in 2023 but does not formally replace the Machinery Directive 2006/42/EC until 2027. F2 Labs performed a deep dive into the two EU regulations to figure out what is new, what is staying, and … Continue reading
Posted in CE marking, Consulting, Machinery Directive 2006/42/EC, UKCA
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Hazardous Location Evaluations – ‘Behind the Scenes’ Details about Intrinsic Safety
Today, I read an email from our HazLoc engineering department that I think is extremely useful not only for F2 Labs personnel, but also for our clients who are working on what is required and how to comply. Your first … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, Machinery Directive 2006/42/EC
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I Want to Send a Flatscreen Monitor to the EU, What Now?
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 … Continue reading
Posted in CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, UL 62368-1
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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 … Continue reading
Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, FCC, FDA, Radio Equipment Directive 2014/53/EU
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