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Recent Posts
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Tag Archives: CE
The Exemption for Medical Devices Under the RoHS Directive Has Expired
The RoHS Directive 2011/65/EU, Article 4 (3) exclusion for industrial monitoring and control instruments expired on Saturday, July 22, 2017. That exclusion was used by quite a few manufacturers to delay RoHS compliance, but Article 4 (3) is now gone. … Continue reading
Posted in CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, RoHS Directive 2011/65/EU
Tagged CE, CE consulting, CE marking, RoHS, RoHS 2011/65/EU
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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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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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The Machinery Directive 2006/42/EC and lifting accessories
The Machinery Directive 2006/42/EC, broadly, is applicable to machinery, defined in Article 2 (a) as an assembly fitted or intended to be fitted with a drive assembly to perform a function. The power, unless used for lifting purposes, must come … Continue reading
Posted in CE marking, Machinery Directive 2006/42/EC
Tagged CE, CE mark, CE marking, EN 13155, EN ISO 12100, EN ISO 12100:2010, Lifting accessories, Machinery Directive, Machinery Directive 2006/42/EC
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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 CE, CE mark, CE marking, EN 60950-1, EN 61010-1, EN 62368-1, Low Voltage Directive 2006/95/EC, Low Voltage Directive 2014/35/EU, LVD, LVD 2014/35/EU, R&TTE, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RED 2015/53/EU
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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 Regulation (EU)2017/745, 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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Standards Used For Radio Product Legislation in the EU
The Radio Equipment Directive 2014/53/EU, or RED, came into force in June of this year. This new Directive replaced the Radio and Telecommunications Terminal Equipment Directive 1999/5/EC for wireless equipment, also called the R&TTE Directive. There is a one-year transition … Continue reading
Posted in CE marking, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU
Tagged 2014/53/EU, CE, CE mark, CE marking, EC declaration of conformity, EN 300 328, EN 301 489-1, EN 301 489-17, EN standards, EU declaration of conformity, EU-type examination, Harmonized EN standards, R&TTE, R&TTE 1999/5/EC, R&TTE Directive 1999/5/EC, Radio and Telecommunications Terminal Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RED 2014/53/EU, RTTE Directive, SAR testing
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Harmonized EN standards, CE marking Directives and your European projects
Silently and slowly – but inexorably… the Directives and standards we use for CE marking are updated, revised, and replaced – and we must account for them. They must be correct when referenced on your declarations of conformity and that … 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 Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged CE, CE consultation, CE marking, CE product testing, CEN, CENELEC, EN ISO 12100:2010, EN ISO 13849-1, EN ISO 13849-1:2008, EN ISO 13849-1:2015, EN standards, Harmonized EN standards, IEC, ISO, Machinery Directive, Machinery Directive 2006/42/EC, MD 2006/42/EC
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The Radio Equipment Directive and the Simplified EU Declaration of Conformity
I first read the new Radio Equipment Directive 2014/53/EU (aka the “RED”) in 2014 when it was published and noted its similarity to the other NLF Framework Directives as it pertains to the documentation compliance process and the conformity modules. … 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 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 CE, CE Certification, CE consulting, CE marking, CE marking certification, CE product testing, Declaration of conformity, EC declaration of conformity, EU certification, EU compliance, EU declaration of conformity, European compliance, Radio Equipment Directive 2014/3/EU, RED 2014/53/EU, RED CE marking
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CE marking and the China Export mark
There are two commonly used markings on equipment that are very similar in appearance but mean different things. The CE marking is a European compliance marking and indicates compliance to all applicable European CE marking Directives (like the Machinery Directive … Continue reading
Posted in CE marking, EMC Directive 2014/30/EU, Machinery Directive 2006/42/EC
Tagged 765/2008/EC, CE, CE marking, China export, China Export mark, EN 60204-1, EN 61010-1, New Legislative Framework, NLF
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