Fragil
The fragile symbol shows a broken wine glass and is standardised in EN ISO 15223-1. It is addressed to logistics, goods-in and warehousing.
Significance for medical devices: what is protected is not only the product itself but above all the sterile barrier system to EN ISO 11607. A hairline crack in the seal seam or a pinhole in the film voids sterility without being externally visible.
Relevance for gloves: sterile surgical gloves in individual peel packs are sensitive to pressure and creasing. Non-sterile examination gloves are less critical, but compression deforms dispenser cartons and impedes single-glove withdrawal.
Goods-in: visibly damaged outer or sterile packaging must be segregated and reported to the supplier; release for use must not occur.
Frequently asked questions
Why do sterile gloves carry the fragile symbol?
Because the sterile barrier system is mechanically sensitive. A hairline crack in the seal seam or a perforation in the film voids sterility without being externally visible. The symbol alerts logistics and warehousing to this sensitivity.
What should be done with damaged packaging at goods-in?
Which standard governs the sterile barrier system?
EN ISO 11607-1 sets requirements for materials and systems for packaging terminally sterilised medical devices; EN ISO 11607-2 covers validation of the packaging processes.