Short name: | In vitro diagnostic medical devices |
Base: | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331 of 7 December 1998 |

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New Standards
Short name: | In vitro diagnostic medical devices |
Base: | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331 of 7 December 1998 |
Base: | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 |
Modification: |
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Base: | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993 |
Modification: |
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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
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:
and the following additions: