Category Archives: RoHS Directive 2011/65/EU

REACH Regulation (EC) No 1907/2006 – Article 7, Annex VII, and practical considerations for manufacturers – the CRASH COURSE

One possible cause for an audible “gulp” coming from the reader of a specifications sheet is coming across a requirement to comply, vaguely, with the REACH Regulation (EC) 1907/2006. Broadly, REACH is meant to ensure that products in Europe do … Continue reading

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CE marking Onsite Consulting and Training

F2 Labs is able to send a CE marking expert to your facility to provide overview training to your business – sales and engineering. We can quickly dig into the Directives that apply to your specific products and show your … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Tagged , , , , , | Comments Off on CE marking Onsite Consulting and Training

Directive (EU) 2017/2102 and RoHS 2011/65/EU

The RoHS Directive 2011/65/EU was amended in November 2017 by Directive (EU) 2017/2102 with some administrative clarifications. I found one item particularly interesting: Recital (2): (2) Secondary market operations for EEE, which involve repair, replacement of spare parts, refurbishment and … Continue reading

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RoHS 2011/65/EU and Machinery

F2 Labs assists many manufacturers, internationally, with CE marking requirements. Regarding CE marking, primarily we test and evaluate electro-mechanical equipment for compliance with electrical safety, machinery safety, EMC and radio, medical device, and hazardous location requirements. However, when a manufacturer … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, 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 | Tagged , , , , , , , , , , | Comments Off on RoHS 2011/65/EU and Machinery

EU’s Rapid Alert System for dangerous non-food products

The EU has a direct conduit for market surveillance authorities to communicate information about non-compliant products directly between 31 EU member nations and the European Commission. This system is called the Rapid Alert System, or RAPEX. This is not where … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, IP Testing, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , | Comments Off on EU’s Rapid Alert System for dangerous non-food products

RoHS 2011/65/EU, EN 50581:2012, and clause 4.3.3.

Manufacturers that send equipment to the EU with a CE marking must understand that a CE marking is a blanket claim by the manufacturer. The claim is that the equipment complies with any applicable CE marking Directive. This article is … Continue reading

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RoHS Directive 2011/65/EU – Article 4 (3) – expired

The RoHS Directive 2011/65/EU, Article 4 (3) exclusion for industrial monitoring and control instruments expired on Saturday, July 22, 2017. That exclusion was used by quite a few manufacturers to delay RoHS compliance, but Article 4 (3) is now gone. … Continue reading

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The EU declaration of conformity

A frequent source of confusion for exporters of products to the EU is the EU declaration of conformity. Many customers that we assist are vaguely familiar with the concept and the role of the “DoC”. The EU declaration of conformity … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , , , , | Comments Off on The EU declaration of conformity

CE marking and the Technical File

Manufacturers who send equipment into the EU are required to send a CE compliant product in most cases. This means that if you are making an electromechanical device, chances are that you will need to comply with at least one, … Continue reading

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , | Comments Off on CE marking and the Technical File

New RoHS restrictions, substances added to Annex II

There is a change on the horizon for manufacturers used to complying with RoHS based on the restriction of the six substances indicated in RoHS 2011/65/EU (Annex II): Lead (0.1%) Mercury (0.1%) Cadmium (0.01%) Hexavalent chromium (0.1%) Polybrominated biphenyls (PBB) … Continue reading

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