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
| Fecha edición: |
2011-05-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This European Standard 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 Section 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. |
| Keywords: | CE marking|Definitions|Graphic representation|Graphic symbols|Information|Labelling|Marking|Medical devices|Medical equipment|Medical instruments|Medical sciences|Medical technology|Phthalates|Phthalic acid|Plasticizers|Specification (approval)|Symbols |
| ICS: | 11.040.01 - Equipo médico en general, 01.080.20 - Símbolos gráficos para uso sobre equipos específicos, 11.120.01 - Productos farmacéuticos en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 15986:2011 |
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Reemplazo Normas |
Reemplaza a DIN EN 15986:2009-08 |
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