S.L. 427.57 Art. 41base material in which are used body fluids and 41a. Lead in used in in vitro nitrogen in 42. systems capable 30 June 2026. 43. and control 2023. 44. centre radiation category 9. 45. care analysis Expires on 21 46. Expires on 1 47. phthalate for the repair devices, and Expires on 21 48. Lead cables

Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as amperometric, potentiometric and conductometric electrochemical sensors in diagnostic medical devices for the analysis of blood and other in vitro body gases. Expires on 31 March 2022. as a thermal stabilizer in polyvinyl chloride (PVC) used as base material amperometric, potentiometric and conductometric electrochemical sensors which are diagnostic medical devices for the analysis of creatinine and blood urea whole blood. Applies to category 8 and expires on 31 December 2023.

Mercury in electric rotating connectors used in intravascular ultrasound imaging of high operating frequency (> 50 MHz) modes of operation. Expires on

Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring instruments, where sensitivity below 10ppm is required. Expires on 15 July

Cadmium in radiation tolerant video camera tubes designed for cameras with a resolution greater than 450 TV lines which are used in environments with ionising exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy. Applies to Expires on 31 March 2027. Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of of ionic substances present in human body fluids and/or in dialysate fluids. July 2028. Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils. January 2024. Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl

(DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used or refurbishment of medical devices, including diagnostic medical in vitro their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. July 2028.

in bismuth strontium calcium copper oxide (BSCCO) superconductor wires and lead in electrical connections to these wires. Expires on 30 June

Mercury in melt pressure transducers for capillary rheometers at temperatures and pressures over 1,000 bar. Applies to category 9 and expires on 31 2025.

Schedule V Applications for granting, renewing and revoking exemptions as referred to in Article 5 of Directive 2011/65/EU for exemptions, renewal of exemptions or, for revoking mutatis mutandis, may be submitted by a manufacturer, the authorised representative of a or any economic operator in the supply chain and shall include at least the name, address and contact details of the applicant; information on the material or component and the specific uses of the substance in the material and component for which an exemption, or its revocation, is requested and its particular characteristics; verifiable and referenced justification for an exemption, or its revocation, in line with the conditions established in Article 5;

(d) an analysis of possible alternative substances, materials or designs cycle basis, including, when available, information about research, peer-review studies and development activities by the an analysis of the availability of such alternatives;

(e) information on the possible preparation for reuse or recycling from waste Electrical and Electronic Equipment, and on relating to the appropriate treatment of waste according to Schedule Waste Management (Electrical and Electronic Equipment) Regulations, (S.L. 504.75).

(f) other relevant information;

(g) the proposed actions to develop, request the development and, possible alternatives including a timetable for such actions by

(h) where appropriate, an indication of the information which should as proprietary accompanied by verifiable justification;

(i) when applying for an exemption, proposal for a precise and clear the exemption;

(j) a summary of the application.

Schedule VI

EU Declaration of Conformity