EN 15986:2011

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

General information

90.93 Standard confirmed   May 31, 2023


CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

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


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.

Related legislation

Legislation related to this standard


Medical devices


Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle


EN 15986:2011
90.93 Standard confirmed
May 31, 2023