Category Archives: Consulting

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 , | Leave a comment

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 Directive 93/42/EEC, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Leave a comment

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 , , , | Leave a comment

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 , , , , | Leave a comment

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

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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 Directive 93/42/EEC, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU, UL 60335-1, UL 61010-1, UL 62368-1 | Leave a comment

RoHS 2011/65/EU and a Tale of Three Guitars

The world has many good guitar manufacturers but it is commonly accepted that the very best guitars are made in the United States. Few guitar players will dispute that. In the world of acoustic guitars there are three ‘big’ manufacturers … Continue reading

Posted in CE marking, Consulting, Product Testing, REACH, RoHS Directive 2011/65/EU | Tagged , , | Leave a comment

Machinery Directive 2006/42/EC, Article 1 (b) interchangeable equipment

As usual, I opened the RAPEX Weekly Report that delivers to my inbox every Friday morning. Scrolling through, I reviewed three cases involving saw blades. These are interesting because they were stopped for violating the Machinery Directive 2006/42/EC. Normally when … Continue reading

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The Machinery Directive 2006/42/EC and Notified Bodies

What is a Notified Body and what does it have to do with the Machinery Directive 2006/42/EC? In most cases presented to us, absolutely nothing. I wanted to write this article because we are asked, from time to time, if … Continue reading

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The Low Voltage Directive 2014/35/EU, its scope, and products that operate from DC voltage.

“F2 Labs is not the EU police and I do not know any EU police.” I say that very often to customers when I speak with them, particularly as it relates to the Low Voltage Directive 2014/35/Eu and its scope, … Continue reading

Posted in CE marking, Consulting, Low Voltage Directive 2014/35/EU, Product Testing, Radio Equipment Directive 2014/53/EU | Leave a comment