Author Archives: Gainspeed

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

Updated on

January 31, 2023 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.

Posted in New Standards/Directives, News |

Our December 2015 Newsletter packed with latest Compliance news!

Updated on

January 31, 2023 by author

Gainspeed

The December Gainspeed newsletter is here. Its a friendly complimentary newsletter on everything compliance.

Some of this months features.

Headlines
Standards Watch
European standards being withdrawn
EU Directives changing
Lists of European Harmonised Standards
Breaking News
Guidance on the new LVD
REACH – Guidance on requirements on substances in articles
A Reminder
“New” version of the CE Marking “Blue Book”
Compliance Calendar

Final draft of ISO 13485 circulated

Updated on

January 31, 2023 by author

Gainspeed

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 version of the CE Marking, “Blue Book”

Updated on

January 31, 2023 by author

Gainspeed

Just a reminder! – the European Commission published a “new” version of “The ‘Blue Guide‘ on the implementation of EU product rules 2014″, (the so called “Blue Book“), in July this year

The new ‘Blue Guide’ builds on the on the content of the Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) published back in 2000, but reflects the modernisation brought to the legal framework in the past decade.

This is not an update as such, as there has been no change to the content – the only difference is in the formatting

Posted in CE Marking, News |