TS EN 15986

TS EN 15986 is the standard for the symbol used in medical device labelling to indicate the presence of phthalates, together with the labelling requirements for using that symbol. Its focus is the clear marking of a medical device, or a part of a medical device, when phthalates are present and the information must be shown on the label.

What the symbol is meant to communicate

In medical device labelling, symbols are used to convey important information in a compact and internationally recognisable form. In this case, the symbol is intended to signal phthalate content. In general technical terms, phthalates are chemical substances used in some polymer and plasticiser applications, so their presence matters for understanding the material make-up of a device or device component.

Scope boundaries of this document

• Defines the format of the symbol used to indicate that phthalates are present in a medical device.
• Applies to the labelling of a medical device or parts of a medical device where this information is required.
• Does not set the requirements for the information supplied with medical devices; those requirements are addressed by EN 980 and EN 1041.
• Does not cover the 1st and 3rd paragraphs of Essential Requirement 7.5.

So TS EN 15986 is not a general medical device labelling code; it is a focused marking standard for phthalate disclosure by symbol. Its value lies in providing a consistent visual cue so that manufacturers and users can identify the presence of phthalates more readily from the label.