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Recent Posts
- Corrosion | Salt Fog Testing: Like taking your product to the beach
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- Adapting to Evolving U.S.-China Regulatory Dynamics
- REACH/RoHS and Continuing Compliance
- FDA Enforcement Flags Data Integrity Risks at Overseas Labs
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Category Archives: Consulting
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 … Continue reading
Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EVs, FCC
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On The Need For Translations
This is an often-asked question, “Do I need to translate the manual for the EU and what do I need to translate?” The answer is everything that is needed top assemble, safely operate, maintain, and eventually dispose of the equipment … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU
Tagged CE marking, EU declaration of conformity
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Important CE Marking Questions and Answers
Frequently at F2 Labs we get deep into various topics regarding CE marking and other compliance requirements. I can only imagine the sinking feeling that a manufacturer must feel when seeing this on a request for bid: CE marking required. … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, General Product Safety Directive 2001/95/EC, GPSR, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU
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F2 sorts out Compliance Requirements for you
Manufacturers contact F2 Labs from around the world for assistance with EU regulations. While F2 Labs primarily focuses on electro-mechanical devices, including medical devices, we have also assisted many people with an understanding of what is legally required. An example … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EU Battery Regulation (EU)2023/152, General Product Safety Regulation (EU) 2023/988, GPSR, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH
Tagged CE marking, EN 60825-1, EN 62368-1, Regulation No (EC) 216/2008
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Ronin Revolution earns EC-Type Examination Certificate
Ronin Revolution Corporation worked with F2 Labs to evaluate and test the Ronin Lift for compliance with the relevant CE marking Directives required to sell their product in Europe. The Ronin Lift is a personal ascender used to lift people … Continue reading
Posted in Batteries, CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230
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CE marking – Equipment is stopped in French customs, what now?
The sales department at F2 Labs fields phone calls from primarily US manufacturers. We have heard every scenario imaginable as pertains CE marking, from, “What is CE marking? We are about to disassemble and crate our machine and noticed that CE … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EU Battery Regulation (EU)2023/152, General Product Safety Regulation (EU) 2023/988, GPSR, 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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Guidance For Wire Colors in Machines in the EU
We help manufacturers every day with the task of CE marking their equipment for shipment to the EU. Very often we are asked questions by our customer’s engineering staff and one of the most common questions pertains to wire colors. … Continue reading
Posted in CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, 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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RoHS 2011/65/EU – New Restrictions July 2019
RoHS 2011/65/EU presently requires compliance for electrical and electronic equipment to these six substances indicated in Annex II: We note that RoHS 2011/65/EU was amended by Commission Delegated Directive (EU) 2015/863 in March of 2015. The new restrictions are highlighted … Continue reading
Posted in CE marking, Consulting, REACH, RoHS Directive 2011/65/EU
Tagged RoHS, RoHS 2011/65/EU, RoHS EU 2015/863, RoHS2, RoHS3
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New RoHS standard – EN 63000:2018
CENELEC has published a new RoHS standard, announcing it, here. The new standard is EN ISO 63000:2018 Technical Documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances. The referenced CENELEC article indicates … Continue reading
Posted in CE marking, Consulting, RoHS Directive 2011/65/EU
Tagged 2011/65/EU, 2015/868, CE, CE mark, CE marking, EN 50581:2012, EN 63000, EN 63000:2018, RoHS
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What is the Critical Component List?
F2 Labs performs safety evaluations & testing, EMC testing, and consulting for various compliance related issues faced by our customers. We open safety evaluations at F2 Labs by sending a list of information we need in order to review the … Continue reading
Posted in CE marking, Consulting, EN 60601-1, General Product Safety Directive 2001/95/EC, Listing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU, UL 60335-1, UL 61010-1, UL 62368-1
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