Back to Top

  • Welcome to gainspeed Ltd,

    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


    We specialise in European and Worldwide approvals.

  • Flexible, Professional, and Affordable Service


    We are a small organisation employing only

    highly experienced associates.

Category: New Standards/Directives

New Standards

UK Packaging (Essential Requirements) Regulations: guidance notes published

Updated on date by author

BIS has just published guidance notes on the UK Packaging (Essential Requirements) Regulations

This guide is addressed to those involved in the placing of packaged goods on the market. This guidance cannot cover every situation and, of course, it may be necessary to carefully consider the relevant legislation to see how it applies in your circumstances. However, if you do follow the guidance it will help you to understand how to comply with the law.

The essential requirements of this regulation are, in summary:
• Packaging volume and weight must be the minimum amount to maintain the necessary levels of safety, hygiene and acceptance for the packed product and for the consumer.
• Packaging must be manufactured so as to permit reuse or recovery in accordance with specific requirements.
• Noxious or hazardous substances in packaging must be minimised in emissions, ash or leachate from incineration or landfill.

 

Posted in New Standards/Directives, News |

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 |
Updated on date by author

Some important significant changes:

EN 50561-1:2013
Power line communication apparatus used in low- voltage installations — Radio disturbance
characteristics – Limits and methods of measurement – Part 1: Apparatus for in-home use
EN 50561-1:2013 supersedes EN 55022:2010 and EN 55032:2012 on 2016-10-09 according to note 2.3

EN 61000-3-2:2014

Electromagnetic compatibility [EMC] — Part 3-2: Limits — Limits for harmonic current emissions
[equipment input current ≤ 16 A per phase] EN 61000-3-2:2014 is newly listed. EN 61000-3-2:2014 supersedes EN 61000-3-2:2006. “date of cessation” for EN 61000-3-2:2006 is 2017-06-30.

Please visit:

http://eur-lex.europa.eu/oj/direct-access.html

 

Posted in New Standards/Directives, News |