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Recent Posts
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- We Offer CE Marking Training For Your Organization
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Category Archives: Product Testing
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
Posted in CE marking, Consulting, Machinery Directive 2006/42/EC, Product Testing
Tagged CE, CE mark, CE marking, CE marking Directives, Declaration of Incorporation, Declaration of incorporation for partly completed machinery, EC declaration of conformity, EU Directives, MD 2006/42/EC, Partly completed machinery
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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 CE, CE mark, CE marking, EU, European Commission, European Union
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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 CE, CE mark, CE marking, EN 50581:2012, EU declaration of conformity, RoHS, RoHS 2, RoHS 2011/65/EU, RoHS compliance, WEEE, WEEE 2012/19/EU
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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 CE, CE mark, CE marking, EU consumer protection, EU market surveillance, European Commission, European compliance, RAPEX, Rapid Alert System
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IP69 and IP69K – What Are They?
We are presented with a request for quote for IP69K testing on a regular basis at F2 Labs. Usually my first reply to the customer is this, “Do you mean IP69 or IP69K?” Believe it or not, there is a … Continue reading
Posted in IP Testing, Product Testing
Tagged IEC 60529, Ingress protection, IP testing, IP69, IP69K, ISO 20653
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CE marking and the ATEX Directive 2014/34/EU
Many times, we receive a request for assistance from a customer for a project that involves, “CE marking and ATEX.” While there is nothing wrong with calling ATEX out separately from other CE marking requirements, we note that the ATEX … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Product Testing
Tagged ATEX, ATEX 2014/34/EU, ATEX Directive 2014/34/EU, ATEX Directive 94/9/EC, CE marking, CE product testing, Declaration of conformity, EC declaration of conformity, EMC 2014/30/EU, EMC Directive 2014/30/EU, EU declaration of conformity, Low Voltage Directive 2006/95/EC, Low Voltage Directive 2014/35/EU, LVD 2014/35/EU, Machinery Directive, Machinery Directive 2006/42/EC, MD 2006/42/EC
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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 ATEX 2014/34/EU, ATEX 94/9/EC, CE marking, Declaration of conformity, EC declaration of conformity, EMC 2004/108/EC, EMC 2014/30/EU, EU declaration of conformity, EU-type Examination Certificate, Low Voltage Directive 2006/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, New Legislative Framework, New Legislative Framework 2008, NLF 2008, Technical File
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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 ATEX 2014/34/EU, CE, CE marking, EMC 2014/30/EU, EMC Directive 2014/30/EU, EN 61326-1, Low Voltage Directive 2014/35/EU, RED 2014/53/EU, RoHS, RoHS 2011/65/EU, RoHS compliance, RoHS Directive 2011/65/EU, Technical File
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Repeal of the Affordable Care Act and the Medical Device Tax
Yesterday afternoon, March 6th, the House Republicans released the bill to repeal (most of) the Affordable Care Act, also known as Obamacare. Since F2 Labs is a safety compliance laboratory, helping many companies comply with regulatory issues when bringing their … Continue reading
Posted in EN 60601-1, Medical Devices Regulation (EU)2017/745, Product Testing
Tagged ACA, EN 60601-1, Medical Device, Medical device excise tax, Medical Device tax, Obamacare, Obamacare repeal bill
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Compliance Requirements for Lasers in the EU
Laser devices sent to Europe are subject to specific safety requirements. Some of these requirements are applicable even if the rest of the device is seemingly innocuous. To start with, we will present a case where a device appears to … Continue reading
Posted in CE marking, General Product Safety Directive 2001/95/EC, Lasers, Product Testing
Tagged CE, CE Certification, CE marking, CE marking lasers, EN 60825-1, F2 Labs, IEC 60825-1, Laser safety
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