Tag Archives: CE mark

Unregulated Certificates Warning and The Implications Under EU Law

Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates. The warning explains that voluntary certificates issued by certification bodies not designated as notified … Continue reading

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EN 62368-1:2014 will replace EN 60950-1 and EN 60065

EN 62368-1:2014 will replace two main EN standards on December 20, 2020. A year or two years ago this seemed a long way off. Now it is right around the corner. To begin with, we want to take a look … Continue reading

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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

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Partly completed machinery and the requirement for Assembly Instructions

Manufacturers who build parts of machines or incomplete machinery (for example: no controls) must be aware that their equipment must not carry a CE marking if the equipment is not in scope of any other Directive(s) and must follow a … 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

Spare Parts and the RoHS Directive

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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Safety Fences and the Machinery Directive 2006/42/EC

While reading the new Guide to application of the Machinery Directive 2006/42/EC, Edition 2.1, I was interested to see that the last sentence in section 42, dealing with Safety Components and their status under the Machinery Directive, is this: Specific … Continue reading

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