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    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


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    (Safety) Directives


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Category: New Standards/Directives

New Standards

New OJ List of Harmonised standards for MD Directive now published

Updated on date by author
Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
OJ L 169 of 12 July 1993
Modification:
  • Directive 93/68/EEC [CE Marking]
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
  • Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Read more…
Posted in Medical Devices Directive, New Standards/Directives, News |

New OJ List of Harmonised standards for Active Implantable Devices now published

Updated on date by author
Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
OJ L 169 of 12 July 1993
Modification:
  • Directive 93/68/EEC [CE Marking]
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
  • Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Read More..

Posted in Medical Devices Directive, 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 |

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 |