Overview

Phthalates are so-called plasticizers: They make plastics elastic. Plasticizers are contained in many user products, from floor coverings, artificial leather and wallpaper to shower curtains and children's toys. Because the toxic effect of phthalates is considered real with some certainty, the EU Commission intervened and a labelling obligation for medical devices containing phthalates was prescribed by law. As a result, the standard has been prepared in the framework of a mandate directed at CEN. It specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC, clause 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041. The European Standard has been prepared by Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (secretariat: NEN, Netherlands) with the participation of German experts. At DIN, the German Institute for Standardization e. V., the Committee responsible for this standard is Working Committee NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at the Medical Standards Committee (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices  

Responsible european committee

CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices