European Union - Draft Amendment to Annex IV to RoHS 2 as Regards an Exemption for Lead as a Thermal Stabiliser in PVC Used in Certain Medical Devices

​Draft Commission Delegated Directive amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. The details are as follows:

"41. Lead as a thermal stabilizer in polyvinly chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluid and body gases.

Expires on [the last day of the 24th month after the publication of the Delegated Directive in the Official Journal]"