EU – RoHS Exemption for the use of Lead in Certain Medical Devices and Monitoring and Control Instruments

​On March 25, 2019, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of lead in bismuth strontium calcium copper oxide superconductor for use in cables and wires and lead in related electrical connections to other EEE components (‘the requested exemption’). Lead-doped BSCCO can be used to create superconducting magnetic circuits for medical devices and monitoring and control instruments. It is currently not possible to substitute or otherwise eliminate lead in the superconducting material and the related solders with the same technical performance, nor is it expected to be so in the foreseeable future. The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (The REACH Regulation) and does not weaken the environmental and health protection afforded by it. Therefore, in Annex IV to Directive 2011/65/EU (RoHS Directive), the following entry is added: ’48 Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables and wires and lead in electrical connections to these wires​. Expires on June 30, 2027.’​

Artículo de publicado en https://www.tuv.com/regulations-and-standards/en/eu-rohs-exemption-for-the-use-of-lead-in-certain-medical-devices-and-monitoring-and-control-instruments.html