Category Archives: EN 60601-1

Critical Component List

Posted on January 18, 2019 by Peter Jolles

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

CE marking Onsite Consulting and Training

Posted on March 6, 2018 by Peter Jolles

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

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

Posted on January 10, 2018 by Peter Jolles

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

The EU declaration of conformity

Posted on May 10, 2017 by Peter Jolles

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

Repeal of the Affordable Care Act and the Medical Device Tax

Posted on March 7, 2017 by Peter Jolles

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