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Category Archives: Medical Devices Directive 93/42/EEC
CE marking FAQ
Frequently at F2 Labs we get very deep into various topics regarding CE marking and other compliance requirements. I can only imagine the sinking feeling that a manufacturer must feel when seeing this on a request for bid: CE marking … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
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Critical Component List
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
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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 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 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 Directive 93/42/EEC, 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 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 CE, CE mark, CE marking, EU consumer protection, EU market surveillance, European Commission, European compliance, RAPEX, Rapid Alert System
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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 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 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 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
CE marking Directives and the Authorized European Representative
The CE marking is placed on products after compliance with all applicable EU CE marking Directives. Some typical examples of CE marking Directives that F2 Labs provides technical support for are indicated below: Machinery Directive 2006/42/EC Low Voltage Directive 2014/35/EU … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU
Tagged ATEX Directive 2014/34/EU, Authorized EU Representative, Authorized European Representative, Authorized Representative, CE, CE marking, Declaration of conformity, EC declaration of conformity, Electromagnetic Compatibility Directive 2014/30/EU, EMC Directive 2014/30/EU, EU declaration of conformity, EU Rep, EU Representative, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Radio Equipment Directive 2014/53/EU, RED 2014/53/EU
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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
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