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    CE Marking Specialists


    A South Wales based Product  Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations


  • Specialists in EMC and Low Voltage

    (Safety) Directives


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Category: New Standards/Directives

New Standards

Final draft of ISO 13485 circulated

Updated on date by author

ISO/FDIS 13485 Medical devices — Quality management systems — Requirements for regulatory purposes Final draft of ISO 13485:2015 has been circulated and is available from BSI:

ISO 13485:2015 is due to be published early 2016.

The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire life cycle of a medical device.

Some of the key changes include:

* Harmonization of regulatory requirements
* Inclusion of risk management throughout the QMS
* Additional clarity with regard to validation, verification, and design activities
* Strengthening of supplier control processes
* Increased focus regarding feedback mechanisms
* Software for QMS, manufacturing and the medical device
Additional information available from BSI:

* Download the BSI white paper on ISO 13485 – The proposed changes and what they mean for you

* Learn more about the ISO 13485 revision

Posted in New Standards/Directives, News |

NEW EMC Standard introduction in 2016! – EN 61000-3-3:2013 (Flicker)

Updated on date by author

EN 61000-3-3:2013 (Flicker) replaces EN 61000-3-3:2008 on 18 June 2016!

This means EVERY AC operated product under the scope of EN 61000-3-3:2008 must be re-assessed, test report modified if necessary or technical justification prepared for the Technical File if no retest is done and a new EU DoC updated to reflect this change!
Most older test equipment used to measure flicker would not have been rated with EN61000-4-15:2011 (new method called in EN 61000-3-3:2013) as such it may be necessary to retest to the new standard or make a technical justification.
Its recommended that you check with the test house that originally tested your equipment, it may also say in your original test report.
If required we can now retest to the latest standard at our facility for you.

Contact us.

 

 

Posted in New Standards/Directives, News |

New standard for in-home power line communication apparatus BS EN 50561-3:2016

Updated on date by author

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What is power line communication?

A common example of this is the home power-line communication adapters commonly used to transfer broadband from one adapter plug to another anywhere in your home. It doesn’t suffer the problems associated with signal loss from walls and obstructions like WIFI. This makes it a great way to get internet from a source connection downstairs to an office upstairs, which normally would be to far away for WIFI signals to reach.

Its also popular in offices, apartments and hotels with some networks crossing across the threshold of properties via distribution networks and premises wiring. Typically transformers prevent propagating the signal, which requires multiple technologies to form very large networks.

Various data rates and frequencies are used in different situations.

 

What is BS EN 50561-3:2016 for?

In-home Power line communication apparatus (PLC) use the mains-electricity wiring in the home for communication by injecting differential-mode (DM) signals. However these signals have the potential to cause interference to the operation of radio or telecommunication apparatus.

To control this situation both radiated-emissions and conducted-emissions tests are now specified, and both are necessary as they control different things. EN 50561-3 applies to equipment that uses frequencies including those above 30 MHz in order to communicate. Procedures are given for the measurement of signals generated by the equipment and limits are specified within the frequency range 9 kHz to 400 GHz. No measurement is required at frequencies where no limits are specified.

The radiated emission requirements in this standard are not intended to be applicable to the intentional transmissions from a radio-transmitter as defined by the ITU, nor to any spurious emissions related to these intentional transmissions.

 

When is BS EN 50561-3:2016 coming out?

latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement
(dop) 2016-11-23

latest date by which the national standards conflicting with this document have to be withdrawn
(dow) 2018-11-23

 

For more information contact us

 

Posted in New Standards/Directives, News |

New Directives on the way! 2014/53/EU, 2014/35/EU and 2014/30/EU

Updated on date by author

Introduction

The European Commission has recently released an Application of Directives. The purpose of this document is to provide guidance on the date of applicability and their transitional period (if any) for the new Directives of the electrical sector.

 

What Directives apply?

 

When do the new Directives apply?

 

Products within OLD LVD/EMCD that continue to be within the NEW LVD/EMCD

Products placed on the market
 Applicable Directive(s)
before 20 April 2016 old LVD/EMCD
after 20 April 2016 new LVD/EMCD

 

Products within R&TTED that continue to be within the RED

Products placed on the market
 Applicable Directive(s)
before 13 June 2016 R&TTED
between 13 June 2016 and 12 June 2017 R&TTED or RED
after 12 June 2017 RED

 

Products within OLD/NEW LVD/EMCD that will be within the RED

Products placed on the market
 Applicable Directive(s)
before 20 April 2016 old LVD/EMCD
between 20 April 2016 and 12 June 2016 new LVD/EMCD
between 13 June 2016 and 12 June 2017 RED or new LVD/EMCD
after 12 June 2017 RED

 

Products within R&TTED that will not be within the RED

Products placed on the market
 Applicable Directive(s)
before 13 June 2016 R&TTED
after 12 June 2016 new LVD (or GPSD)(1)/EMCD

(1)If the LVD is not applicable (eg if the supply voltage is too low) the General Product Safety Directive could be applicable provided that the equipment is a consumer product.

Posted in New Standards/Directives, Uncategorized |

Latest Standards Changes 2017

Updated on date by author

Lots of changes on the horizon for 2017, to help you keep up to date here is a list of the latest.

New Standard Name Replaced Standard DoW
ICES-005, Issue 4 Lighting Equipment ICES-005, Issue 3 01/12/16
EN 50242:2016 /EN 60436:2016 Electric dishwashers for household use – Methods for measuring the performance EN 50242:2008 / EN 60436:2008. 11/4/18
EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests EN 60601-1-2:2007 31/12/18
EN 60730-2-6:2016 Automatic electrical controls – Part 2-6: Particular requirements for automatic electrical pressure sensing controls including mechanical requirements EN 60730-2-6
 26/02/19
EN 62841-2-8:2016 Particular requirements for hand-held shears and nibblers EN 60745-2-8:2009
 20/05/20
EN 55014-2:2015 Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 2: Immunity – Product family standard EN 55014-2:1997 + A1 + A2 not harmonized
EN 303 345 V1.1.1 Radio Broadcast Receivers; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU   not harmonized
EN 303 406 V1.1.0 (2016-05) Short Range Devices (SRD); Social Alarms Equipment operating in the frequency range 25 MHz to 1 000 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU   not harmonized
EN 301 893 V2.0.7 (2016-11) 5 GHz RLAN; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU   not harmonized
EN 301 489-52 V1.1.0 (2016-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 52: Specific conditions for Cellular Communication Mobile and portable (UE) radio and ancillary equipment; Harmonised Standard covering the essential requirements of article 3.1b of Directive 2014/53/EU   not harmonized
EN 301 489-50 V2.1.1 (2016-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 50: Specific conditions for Cellular Communication Base Station (BS), repeater and ancillary equipment; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU   not harmonized
EN 301 489-34 V2.1.0 (2016-05) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones; Harmonised Standard covering the essential requirements of article 3.1b of the Directive 2014/53/EU and the essential requirements of article 6 of the Directive 2014/30/ EU   not harmonized
ETSI EN 301 489-17 V3.1.1 (2016-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU   not harmonized
ETSI EN 301 489-9 V2.1.0 (2016-09) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 9: Specific conditions for wireless microphones, similar Radio Frequency (RF) audio link equipment, cordless audio and in-ear monitoring devices; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU   not harmonized
ETSI EN 301 489-3 V2.1.0 (2016-09) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU   not harmonized
EN 301 489-1 V2.1.1 (2016-11) ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU   not harmonized
ETSI EN 300 440 V2.1.0 (2016-05) Short Range Devices (SRD); Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU   not harmonized
ETSI EN 300 330 V2.1.1 (2016-11) Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU   not harmonized
ETSI EN 300 220-1 V3.1.1 (2016-11) Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz; Part 1: Technical characteristics and methods of measurement   not harmonized
ETSI EN 300 220-2 V3.1.1 (2016-11) Short Range Devices (SRD) operating in the frequency range 25 MHz to 1 000 MHz; Part 2: Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU for non specific radio equipment   not harmonized
EN 300 328 V2.1.1 Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU   13th January 2017
EN 60730-1:2016 Automatic electrical controls – Part 1: General requirements   not harmonized

 

Posted in New Standards/Directives, News, Uncategorized |