TS EN 15986

TS EN 15986 is the Turkish edition of the standard that defines the symbol used to label medical devices containing phthalates and sets out the requirements for that symbol’s form. Its core purpose is to make the presence of phthalates in a device or in parts of a device clearly visible on the label. In the broader technical context, graphic symbols help convey product information consistently across languages and markets.

Why phthalate labelling matters technically

Phthalates are chemicals used as plasticizers in some materials and components, and their presence in medical devices may need to be indicated in specific regulatory situations. This standard focuses on how that presence is represented on the label; it does not define how the device is manufactured, what materials must be used, or any clinical suitability criteria. As a matter of general technical practice, a standardized symbol supports clear communication and reduces dependence on text alone.

What is covered, and what is not

The subject of this document is the format of the labelling symbol. The standard does not address the broader requirements for information supplied with medical devices; those are handled by EN 980 and EN 1041. In practical terms, TS EN 15986 standardizes the symbol itself, not the full wording of label text, instructions for use, or other product information.

• The symbol format used to indicate the presence of phthalates
• Labelling of a medical device or parts of a medical device
• Situations required by Annex I, Section 7.5, second paragraph of Directive 93/42/EEC
• Symbol-based labelling, not the full content of accompanying device information