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BSI BS EN 15986:2011

Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
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BSI BS EN 15986:2011

Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

PUBLISH DATE 2011
PAGES 16
BSI BS EN 15986:2011

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.

This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.

SDO BSI: British Standards Institution
Document Number EN 15986
Publication Date March 31, 2011
Language en - English
Page Count 16
Revision Level
Supercedes
Committee CH/210/3
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