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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


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    (Safety) Directives


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Category: New Standards/Directives

New Standards

List of Harmonised Standards for the new EMC Directive (2014/30/EU) published in the OJ

Updated on date by author

A list of Harmonised Standards for the new EMC Directive (2014/30/EU) was published in the Official Journal on 13th May 2016.

Compared to the last list published for the old EMC Directive (2004/108/EC) there are:

Some observations

It appears some standards have been removed for two reasons:

  1. They have expired, or
  2.  They will be moved to the Radio Equipment Directive, including..
  • EN 55013:2013 – Sound and television broadcast receivers and associated equipment – Radio disturbance characteristics – Limits and methods of measurement
  • EN 55020:2007 – (and amendments) Sound and television broadcast receivers and associated equipment – Immunity characteristics – Limits and methods of measurement
  • EN 55022:2010 – Information technology equipment – Radio disturbance characteristics – Limits and methods of measurement
  • EN 55032:2012 – Electromagnetic compatibility of multimedia equipment – Emission requirements
  • EN 55103-1:2009 (and amendments) Electromagnetic compatibility – Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use – Part 1: Emissions

We are now in a one year transition for the Radio Equipment Directive.

This means that for Products within OLD/NEW LVD/EMCD that will be within the RED, there is a choice of which Directive(s) to apply when considering products placed on the market and applicable Directive(s)

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

However, there are now no harmonised standards under the new EMC Directive (2014/30/EU) for:

  • Sound and television broadcast receivers and associated equipment

Also there are no harmonised emission standards under the new EMC Directive (2014/30/EU) for:

  • Information technology equipment
  • multimedia equipment
  • Audio, video, audio-visual and entertainment lighting control apparatus for professional use

So its unclear if there is a transition period at this time.

Posted in EMC Directive, New Standards/Directives, News |

New List of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) published in the Official Journal

Updated on date by author

A new list of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) was published in the Official Journal on May 13, 2016 – OJ C173

9 new standards have been added:

  • EN 556-2:2015 (new) Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices
  • EN 1865-1:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment
  • EN 1865-2:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher
  • EN ISO 3826-4:2015 (new) Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
  • EN ISO 11137-1:2015 (new) Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
  • EN ISO 11137-2:2015 (new) Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
  • EN ISO 13408-1:2015 (new) Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
  • EN ISO 13408-7:2015 (new) Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
  • EN 60601-1-2:2015 (new) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral
    Standard: Electromagnetic disturbances – Requirements and tests
Posted in Medical Devices Directive, New Standards/Directives, News |

New lists of harmonised standards published

Updated on date by author

At the end of last week there were 4 publications in the Official Journal that may be of interest:

[8th July 2016] Correction published for the list of harmonised standards for the In vitro diagnostic medical devices Directive (98/79/EC)

[8th July 2016] The first list of harmonised standards published for the Radio Equipment Directive (2014/53/EU)

At the moment this is a very small list, containing only 4 standards !

[8th July 2016] The first list of harmonised standards published for the Low Voltage Directive (2014/35/EU)

[8th July 2016] New list of harmonised standards published for the R&TTE Directive (1999/5/EC)

Posted in New Standards/Directives, News |

ETSI EN 300 328 V2.1.1 has now been published

Updated on date by author

 

ETSI 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” has now been published.

This is the first published version of this standard covering Directive 2014/53/EU (Radio Equipment)

Available free of charge from ETSI:  ETSI EN 300 328 V2.1.1

It is not yet published in the OJEU but the proposed national transposition dates are:

Date of latest announcement of this EN (doa): 28 February 2017

Date of latest publication of new National Standard or endorsement of this EN (dop/e): 31 August 2017

 

Major changes introduced in this version:

  • Inclusion of Receiver Blocking as a new requirement.
  • Inclusion of an alternative test method for Power Spectral Density.
  • Modifications required for alignment with the Directive 2014/53/EU [i.1].
  • Reduction of minimum number for hopping frequencies for non-adaptive FHSS equipment.
Posted in New Standards/Directives, News, Radio Equipment |

Guidelines for the application of ISO 9001:2015 published

Updated on date by author

PD ISO/TS 9002:2016 Quality management systems — Guidelines for the application of ISO 9001:2015 has recently been published

This document has been developed to assist users to apply the quality management system requirements of ISO 9001:2015, and provides guidance, with a clause by clause correlation to Clauses 4 to 10 of ISO 9001:2015, (although it does not provide guidance on Annexes A and B). It gives examples of what an organization can do, but it does not add new requirements to ISO 9001.

The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization, and include descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization.

While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes.

Posted in New Standards/Directives, News, Quality management systems |