Category Archives: Product Testing

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 Directive 93/42/EEC, 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 , , , , , , , , | Leave a comment

IP69 vs. IP69K

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

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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

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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 Directive 93/42/EEC, 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 , , , , , , , , , , , , , , , | Leave a comment

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 Directive 93/42/EEC, 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 , , , , , , , , , , , , | Leave a comment

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 Directive 93/42/EEC, Product Testing | Tagged , , , , , , | Leave a comment

Lasers, IEC/EN 60825-1, the Low Voltage Directive 2014/35/EU, and the General Product Safety Directive 2001/95/EC

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 , , , , , , , | Leave a comment

UL 94 testing

UL 94 is a standard that measures, in a laboratory setting, the burn characteristics of plastic materials. The title of the standard itself is pretty descriptive: UL Standard for Safety for Tests for Flammability of Plastic Materials for Parts in … Continue reading

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Compliance with the Low Voltage Directive 2014/35/EU, Annex I

F2 Labs is constantly working to help customers better understand their responsibilities in complying with CE marking Directives that may or may not apply to their equipment. Previously we published an article about the relationship between the Low Voltage Directive 2014/35/EU … Continue reading

Posted in CE marking, Low Voltage Directive 2014/35/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU | Tagged , , , , , , , , , , , , , | Leave a comment

CE markings, Ex markings, and other EU markings claiming product compliance

Manufacturers who build equipment for sale to customers in the European Union may spend a lot of time learning about and understanding the process that is required in order to sell their products with a CE marking on it. Placing … 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 Directive 93/42/EEC, 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 | Leave a comment