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    (Safety) Directives


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Category: New Standards/Directives

New Standards

BS EN 60601-1-2:2015 published

Updated on date by author

BS 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” has been published and is available through the BSI website article.

The most significant changes with respect to the previous edition include the following modifications:

  • specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with iec 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;
  • specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable rf communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition;
  • specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system;
  • specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and
  • better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”;

and the following additions:

  • guidance for determination of immunity test levels for special environments;
  • guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable;
  • guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and
  • guidance on identification of immunity pass/fail criteria.
Posted in New Standards/Directives, News |

New BS EN PUBLICATIONS (BS EN 50561-3:2016 & BS EN 62321-7-1:2015)

Updated on date by author

BS EN PUBLICATIONS Update to standards March 2016

BS EN 50561-3:2016
Power line communication apparatus used in low-voltage installations. Radio disturbance characteristics. Limits and methods of measurement. Apparatus operating above 30 MHz (See previous post)

BS EN 62321-7-1:2015
Determination of certain substances in electrotechnical products. Determination of the presence of hexavalent chromium (Cr(VI)) in colorless and colored corrosion-protected coatings on metals by the colorimetric method

Posted in New Standards/Directives, News |

New IEC PUBLICATIONS (IEC 60598-1, IEC 60695-1-20:2016 & IEC 62911:2016)

Updated on date by author

IEC PUBLICATIONS Update to standards March 2016

IEC 60598-1
Luminaires. General requirements and tests

IEC 60695-1-20:2016
Fire hazard testing. Guidance for assessing the fire hazard of electrotechnical products. Ignitability. General guidance

IEC 62911:2016
Audio, video and information technology equipment. Routine electrical safety testing in production

Posted in New Standards/Directives, News |

The first Hazard Based Standard, EN 62368-1:2014 Safety of Multimedia products

Updated on date by author
EN 62368-1:2014 Audio/video, information and communication technology equipment – Part 1: Safety requirements
is coming and a date of withdrawal (DOW) for the 60950-1 and 60065 standards has been announced, with a five-year transition to 2019. Manufacturers must demonstrate compliance to EN 62368-1 for all products placed on the market after the DOW.
The recommendation is that if a product or series is going to be withdrawn from the markets by 2018, then keep the old standards in place. If it is anticipated that production will continue beyond that, then look into obtaining certification to EN 62368, but keep the 60950-1 and 60065 files current.
See the latest EU Official journal LVD for more information on changes in the pipeline.
You can also purchase the standard on the BSI website.
Posted in New Standards/Directives, News |

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 |