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News > EU RoHS Directives and Regulations > EU RoHS 2 amends exclusion clauses for medical and monitoring equipment

EU RoHS 2 amends exclusion clauses for medical and monitoring equipment

  • 2014-07-03

EU RoHS 2 amends exclusion clauses for medical and monitoring equipment

January 23, 2014

In addition to publishing the exclusion items for Annex III in the Official Journal on 9 January 2014, the European Commission also published a series of revised directives on the same day regarding the exclusion items for medical and surveillance equipment (Annex IV), which came into effect 20 days after publication.

 Items not subject to regulation and exemption datesinstruction
Added item 23Lead is an alloying element used in the wear surfaces of bearings in medical devices exposed to ionizing radiation. The expiration date is June 30, 2021.2014/1/EU
Added item 21Cadmium is used in the fluorescent coating of X-ray imaging/image intensifiers. This is intended as a spare part for X-ray systems with an expiration date of December 31, 2019, and those placed on the market before January 1, 2020.2014/2/EU
Added item 22Lead acetate labeling for head stereotactic frames used in CT and MRI, and positioning systems for gamma-ray and particle therapy equipment. Expiry date: June 30, 2021.2014/3/EU
Added 24th itemLead is used to enhance the vacuum-sealed connection between aluminum and steel in X-ray image intensifiers. Expiry date is December 31, 2019.2014/4/EU
Added 26th itemLead is intended for use where continuous operation and storage conditions are below -20 °C: — Solder for printed circuit boards; — Terminal coatings for electronic and electrical components and coatings for printed circuit boards; — Solder for connecting wires and cables; — Solder for connecting sensors and inductors; Expiry date: June 30, 2021.2014/5/EU
Added 25th itemLead must be used in the surface coating of pin connector systems (non-magnetic connectors) under normal operating and storage conditions below -20 °C. The expiration date is June 30, 2021.2014/6/EU
Added 27h itemUsed in a magnetic field with a radius of 1 meter centered on medical magnetic resonance imaging equipment, including patient monitoring instruments designed for use within this area, or cyclotron magnets for particle therapy, and a magnetic field 1 meter outside the surface of the magnet for beam transmission and beam direction control. Lead is used in: — solder, — terminal coatings for electronic and electrical components and printed circuit boards, — wire connections, protection and enclosed connectors. Expiry date: June 30, 2020.2014/7/EU
Added item 28Lead in the solder used to embed cadmium telluride and cadmium zinc telluride digital array detectors into printed circuit boards. Expiry date: December 31, 2017.2014/8/EU
Amend item 12Lead and cadmium in the metal wires used to generate superconducting magnetic circuits in MRI and SQUID/NMR (nuclear magnetic resonance) or FTMS (Fourier transform mass spectrometer) detectors. Expiry date: June 30, 2021.2014/9/EU
Added item 29Lead in alloys, as a superconductor or thermal conductor, for use in medical devices (Class 8) and/or in industrial monitoring and control instruments, cold heads of cryo-coolers and/or cold probes of cryo-coolers and/or equipotential bonding systems of cryo-coolers. Expiry date: June 30, 2021.2014/10/EU
Added 30th itemHexavalent chromium is used in alkali metal dispensers that generate photocathodes in X-ray image intensifiers. This is intended as a spare part for X-ray systems with an expiration date of December 31, 2019, and those placed on the market before January 1, 2020.2014/11/EU
Added item 32Lead in the solder of printed circuit boards used in positron emission tomography (PET) devices, which are integrated into the detectors and data acquisition units of magnetic resonance imaging (MRI) equipment. Expiry date: December 31, 2019.2014/12/EU
Added item 33Lead in the solder of printed circuit boards (excluding portable defibrillators) used in Class IIa and IIb mobile medical devices as defined in Directive 93/42/EEC.
For Class IIa, the expiry date is June 30, 2016.
For Class IIb, the expiry date is December 31, 2020.
2014/13/EU
Added item 31Lead, cadmium, and hexavalent chromium in reused spare parts; medical devices placed on the EU market before 22 July 2014 and Category 8 devices placed on the EU market before 22 July 2021. Expiry date: 21 July 2021.2014/15/EU
Added item 34Lead is used as an activator in the phosphor of a discharge lamp containing BSP (BaSi2O5:Pb) for use in extracorporeal photochemotherapy. The expiration date is July 22, 2021.2014/16/EU

Note: This Chinese translation is for reference only. For relevant laws and regulations, please refer to the original text.

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