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Category: News

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 |

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 |