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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: 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 |