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Standard [CURRENT]

DIN EN 15986:2011-05

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM

German title
Symbol zur Kennzeichnung von Medizinprodukten - Anforderungen zur Kennzeichnung von phthalathaltigen Medizinprodukten; Deutsche Fassung EN 15986:2011, mit CD-ROM
Publication date
2011-05
Product with additional digital content.
TIF
Additional digitale content will be provided based on format and purchase option. Please note any information in the document.
Original language
German
Pages
14

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Publication date
2011-05
Product with additional digital content.
TIF
Additional digitale content will be provided based on format and purchase option. Please note any information in the document.
Original language
German
Pages
14
DOI
https://dx.doi.org/10.31030/1728168

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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).

Content
ICS
01.080.20, 11.040.01, 11.120.01
DOI
https://dx.doi.org/10.31030/1728168

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