BS EN 15986:2011

This standard BS EN 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates is classified in these ICS categories:

• 11.040.01 Medical equipment in general
• 11.120.01 Pharmaceutics in general
• 01.080.20 Graphical symbols for use on specific equipment

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, 2^nd 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 1^st and of the 3^rd paragraphs of Essential Requirement 7.5.