Textual Amendments
F1 Substituted by Commission Delegated Directive 2014/9/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 and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors (Text with EEA relevance).
Textual Amendments
F2 Inserted by Commission Delegated Directive 2014/2/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 cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020 (Text with EEA relevance).
Textual Amendments
F3 Inserted by Commission Delegated Directive 2014/3/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 acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment (Text with EEA relevance).
Textual Amendments
F4 Inserted by Commission Delegated Directive 2014/1/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 as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation (Text with EEA relevance).
Textual Amendments
F5 Inserted by Commission Delegated Directive 2014/4/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 enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers (Text with EEA relevance).
Textual Amendments
F6 Inserted by Commission Delegated Directive 2014/6/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 the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions (Text with EEA relevance).
solders on printed circuit boards,
termination coatings of electrical and electronic components and coatings of printed circuit boards,
solders for connecting wires and cables,
solders connecting transducers and sensors,
that are used durably at a temperature below – 20 °C under normal operating and storage conditions.
Expires on 30 June 2021 .]
Textual Amendments
F7 Inserted by Commission Delegated Directive 2014/5/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, 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, termination coatings of electrical and electronic components and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers and sensors that are used durably at a temperature below – 20 °C under normal operating and storage conditions (Text with EEA relevance).
solders,
termination coatings of electrical and electronic components and printed circuit boards,
connections of electrical wires, shields and enclosed connectors,
which are used in
magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or
magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.
Expires on 30 June 2020 .]
Textual Amendments
F8 Inserted by Commission Delegated Directive 2014/7/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used (a) in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or (b) in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy (Text with EEA relevance).
Textual Amendments
F9 Inserted by Commission Delegated Directive 2014/8/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards (Text with EEA relevance).
Textual Amendments
F10 Inserted by Commission Delegated Directive 2014/10/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments (Text with EEA relevance).
Textual Amendments
F11 Inserted by Commission Delegated Directive 2014/11/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 hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020 (Text with EEA relevance).
Textual Amendments
F12 Inserted by Commission Delegated Directive 2014/15/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, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer (Text with EEA relevance).
Textual Amendments
F13 Inserted by 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).
Textual Amendments
F14 Inserted by Commission Delegated Directive 2014/13/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 populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators (Text with EEA relevance).
Textual Amendments
F15 Inserted by Commission Delegated Directive 2014/16/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 as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors (Text with EEA relevance).