SS-EN-15986 › Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

SS-EN-15986 - 2011 EDITION - CURRENT


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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.

To find similar documents by classification:

01.080.20 (Graphical symbols for use on specific equipment Standards included in this group shall also be included in other groups and/or sub-groups according to their subject)

11.040.01 (Medical equipment in general)

11.120.01 (Pharmaceutics in general)


Medical devices

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Designation Name

SS-EN 15986:2011

Revision Level

2011 EDITION

Status

Current

Publication Date

March 9, 2011

Language(s)

English

Page Count

24

International Equivalent

EN 15986:2011(IDT)