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Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices Text with EEA relevance · European Union

In Annex IV to Directive 2011/65/EU, the following point 41 is added: ‘41. Lead as a thermal stabiliser in polyvinyl 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 fluids and body gases. Expires on 31 December 2018.’

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Source: EUR-Lex (Cellar) · retrieved 2026-10-18 · Text as adopted (Official Journal); later amendments are not incorporated in this text.