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  • 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: News

Our September 2015 Newsletter packed with latest Compliance news!

Your free comprehensive guide, perfect for saving you time.

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

Some of this months features.

Standards Watch
European standards being withdrawn
EU Directives changing
Lists of European Harmonised Standards
Breaking News
UK Packaging (Essential Requirements) Regulations – Guidelines
A Reminder
The CE mark – what should it look like
New Standards
Compliance Calendar

Posted in News, News Letter |

Conflict minerals: MEPs ask for mandatory certification of EU importers

Conflict minerals: MEPs ask for mandatory
certification of EU importers

EU importers of tin, tantalum, tungsten and gold for manufacturing consumer goods
need to be certified by the EU to ensure that they do not fuel conflicts and human
rights abuses in conflict areas, say MEPs in their position on a draft law adopted on
Wednesday by 402 votes to 118, with 171 abstentions.

Read More

Posted in News, RoHS Directive |

BS EN 60601-1-2:2015 published

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.