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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

(2) Blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements.

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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.