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On September 22, 2022, the European Union published two directives in its Official Journal Directive (EU) 2022/1631 and Directive (EU) 2022/1632 (EU) to amend the RoHS Directive, adding two new exemptions on lead in Annex IV. RoHS Annex IV Exemptions for medical devices and monitoring equipment. The relevant content of the two new exemptions are as follows:
(EU) 2022/1631 added exemption Item 48 in RoHS Annex IV:
Item | Exemption | Scope and dates of applicability |
48 | Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables and wires and lead in electrical connections to these wires. | 2027.6.30 |
(EU) 2022/1632 added two exemptions (c) and (d) on the original exemption Item 27 in RoHS Annex IV:
Item | Exemption | Scope and dates of applicability |
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; | 2020.6.30 | |
(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; | 2020.6.30 | |
(c) MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before 23 September 2022; | 2027.6.30 | |
(d) MRI devices including integrated coils, 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, for which the Declaration of Conformity is issued for the first time before 30 June 2024. | 2027.6.30 |
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