Today, the BBC published this article on failing active implantable medical devices:Read More
European Commission Publishes Updated Borderline & Classification Manual
On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications.Read More
ATEX Directive: New List of European Harmonised Standards Published
On the October, 2018, the European Commission published a new list of European harmonised standards for the ATEX Directive (2014/34/EU)
If the ATEX Directive applies to your products, we recommend you to check if the standards you or your suppliers have used have been amended, or that new relevant standards have been included in the list.
The following standards have been added to the list for the Low Voltage Directive:
EN 17077:2018 – Determination of burning behaviour of dust layers
EN ISO/IEC 80079-38:2016 – Explosive atmospheres — Part 38: Equipment and components in explosive atmospheres in underground mines (ISO/IEC 80079-38:2016)
EN ISO/IEC 80079-38:2016/A1:2018
EN 50271:2018 – Electrical apparatus for the detection and measurement of combustible gases, toxic gases or oxygen — Requirements and tests for apparatus using software and/or digital technologies
The PDF documents with the new lists of standards have been added to the CE Marking Library of our online platform already. The new and amended standards are being included in the standards database.
If you have questions, please let us know.
EN 12312-6 Superseded
On 30 September 2017, the EN 12312-6:2014 + A1:2009 for Aircraft ground support equipment – Specific requirements – Part 6: De-icers and de-icing/anti-icing equipment was supeseded by the version EN 12312-6:2017. The superseded version may not be used as proof of conformity with the Machinery Directive (2006/42/EC).
Household Standards Superseded
Today (September 29, 2017), the following European harmonised standards are superseded:
EN 60335-2-23:2003 – Household and similar electrical appliances – Safety – Part 2-23: Particular requirements for appliances for skin or hair care is superseded by the version A2:2015.
EN 60335-2-97:2006 – Household and similar electrical appliances – Safety – Part 2-97: Particular requirements for drives for rolling shutters, awnings, blinds and similar equipment and its amendments are superseded by version A12:2015.
New Lists of European Harmonised Standards Published
On the September 8, 2017, the European Commission published a new list of European harmonised standards for the following directives:
- the Low Voltage Directive (2014/35/EU)
- the ATEX Directive (2014/34/EU)
If any of these directives apply to your products, we recommend you to check if the standards you or your suppliers have used have been amended, or that new relevant standards have been included in the list.
The following standards have been added to the list for the Low Voltage Directive:
EN 60335-2-9:2003 – Household and similar electrical appliances — Safety — Part 2- 9: Particular requirements for grills, toasters and similar portable cooking appliances – IEC 60335-2-9:2002 (Modified);
EN 60335-2-9:2003/A2:2006 – IEC 60335-2-9:2002/A2:2006;
EN 60335-2-9:2003/A13:2010/AC:2012 ;
EN 60335-2-9:2003/A13:2010/AC:2011 ;
EN 60335-2-9:2003/A13:2010 ;
EN 60335-2-9:2003/A12:2007 ;
EN 60335-2-9:2003/A1:2004 IEC 60335-2-9:2002/A1:2004 .
The following standards have been added to the list for the ATEX Directive:
EN 1839:2017 – Determination of the explosion limits and the limiting oxygen concentration (LOC) for flammable gases and vapours;
EN 14986:2017 – Design of fans working in potentially explosive atmospheres;
EN ISO 16852:2016 – Flame arresters — Performance requirements, test methods and limits for use (ISO 16852:2016);
EN 60079-30-1:2017 – Explosive atmospheres — Part 30-1: Electrical resistance trace heating — General and testing requirements (IEC/IEEE 60079-30-1:2015 (Modified)).
The PDF documents with the new lists of standards have been added to the CE Marking Library of our online platform already. The new and amended standards are being included in the standards database.
If you have questions, please let us know.