Commission Delegated Directive 2014/12/EU
of 18 October 2013
amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on printed circuit boards of detectors and data acquisition units for Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging equipment
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment1, and in particular Article 5(1)(a) thereof,
Whereas:
Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.
Strong vibrations occur in Positron Emission Tomographs which are integrated into Magnetic Resonance Imaging. Research has shown that lead-free solders that have been investigated for vibration susceptibility are more vulnerable to early failure under the severe vibration conditions than bonds made with tin/lead solder. The specific conditions and geometrical restrictions of the equipment restrict the applicability of mechanical measures that could eliminate or sufficiently mitigate the effects of the intense vibration.
Substitution or elimination of lead is currently scientifically and technically impracticable. A temporary exemption is needed to allow manufacturers sufficient time for research to identify suitable lead-free materials and designs.
Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE: