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Category Archives: Consulting
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. This certification … 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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HazLoc Evaluations – Behind the Scenes Information 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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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 … Continue reading
Posted in CE marking, Consulting, RoHS Directive 2011/65/EU
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Translations and CE marking
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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CE marking FAQ
Frequently at F2 Labs we get very 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 … 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, 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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Sending equipment to the EU when compliance is not an obvious path
Manufacturers contact F2 Labs from around the world to ask 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. … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC
Tagged CE marking, EN 60825-1, EN 62368-1, Regulation No (EC) 216/2008
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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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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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