Warnhinweis
EN ISO 15223-1 distinguishes two related but not equivalent symbols.
1. "Consult instructions for use": blue pictogram with an open book. It obliges the user to read the accompanying documents before use. Under MDR (EU) 2017/745 Annex I it is routinely required on medical devices whose use is not self-explanatory.
2. "Caution" or warning: black exclamation mark in a triangle. It points to a specific hazard or limitation explained in the accompanying documents.
Distinction from ISO 7010: safety signs for workplaces are governed by ISO 7010 and apply to on-site signage, not to product labelling of medical devices.
Typical content for gloves: allergy notices on natural latex and vulcanisation accelerators, chemical resistance data and wearing-time limits.
Frequently asked questions
What is the difference between "consult IFU" and the warning triangle?
The blue book symbol is a general instruction to read the accompanying documents. The exclamation mark in a triangle additionally flags a specific hazard or limitation explained in the instructions for use.
Does ISO 7010 also apply to medical device labelling?
No. ISO 7010 standardises safety signs for workplaces and signage. For medical device labelling, EN ISO 15223-1 applies; the two systems are not mixed.
What warnings are typical on gloves?
Typical notices cover natural latex proteins and vulcanisation accelerators as potential allergy triggers, resistance data for specific chemicals, and maximum wearing times under chemical contact.