9 January 2014, European Commission has published a series of directives form 2014/1/EU to 2014/16/EU, amending the Annex III and Annex IV to Directive 2011/65/EU. A new item have been inserted in the Annex III ,14 new items have been added and a content have been replaced in the Annex IV.
The amending specific contents were shown in table 1, 2, 3.
At present, There were 40 items in the Annex III and 34 items in the Annex IV, which was about the exemption of medical devices and monitoring and control instruments in the Annex IV. The series of directives shall enter into force on 29 January 2014, and bring into force the laws by 1 July 2014.
The inserted point | |||
2014/14/EU | 1(g) | For general lighting purposes < 30 W with a lifetime equal or above 20000 h: 3,5 mg. | Expires on 31 December 2017 |
Directive NO. | Added NO. | Added content |
2014/2/EU | 21 | 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 |
2014/3/EU | 22 | Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment. Expires on 30 June 2021. |
2014/1/EU | 23 | Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. Expires on 30 June 2021. |
2014/4/EU | 24 | Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers. Expires on 31 December 2019. |
2014/6/EU | 25 | 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. Expires on 30 June 2021. |
2014/5/EU | 26 | 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. Expires on 30 June 2021. | ||
2014/7/EU | 27 | 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 in | ||
(a) 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) 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. | ||
2014/8/EU | 28 | Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards. Expires on 31 December 2017. |
2014/10/EU | 29 | 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. Expires on 30 June 2021. |
2014/11/EU | 30 | 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. |
2014/15/EU | 31 | 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. Expires on 21 July 2021. |
2014/12/EU | 32 | 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. Expires on 31 December 2019. |
2014/13/EU | 33 | 33.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. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb |
2014/16/EU | 34 | Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5 :Pb) phosphors. Expires on 22 July 2021. |
Directive NO. | The old point | |
2014/9/EU | Lead and cadmium in metallic bonds to superconducting materials in MRI and SQUID detectors. |
Safety/EMC/Wireless
Inspection & Audit
Testing/Compliance/Consultation
(USA & CANADA)
