Nicht wiederverwendbar
The "do not re-use" symbol consists of a crossed-out figure 2 and is standardised in EN ISO 15223-1. It must appear on all single-use products whose intended purpose provides for one application only.
Regulatory significance: the manufacturer's intended purpose determines whether a device is single-use or reusable. Anyone who reprocesses a device labelled single-use and places it on the market again is, under MDR (EU) 2017/745 Article 17, generally regarded as the manufacturer of the reprocessed device and assumes the full manufacturer obligations.
Technical background: cleaning and sterilisation alter the barrier properties of thin-walled elastomers. Neither leak-tightness to EN 455-1 nor force at break to EN 455-2 can be reliably restored after reprocessing.
Scope: the symbol specifically does not apply to reusable surgical instruments of Class Ir, where the manufacturer validates the reprocessing cycle.
Frequently asked questions
Why must single-use gloves not be reprocessed?
Cleaning and sterilisation alter the material properties of thin-walled elastomers. Leak-tightness to EN 455-1 and force at break to EN 455-2 cannot be reliably restored afterwards. Reprocessing is also outside the manufacturer's stated intended purpose.
What does the "do not re-use" symbol look like?
It shows the figure 2 with a diagonal line through it. The design is standardised in EN ISO 15223-1 and is internationally uniform, so no translation is required.
What are the consequences of reprocessing a single-use device?
Under MDR Article 17, anyone reprocessing a single-use device and placing it on the market again is generally regarded as the manufacturer of the reprocessed device. All manufacturer obligations, including conformity assessment and liability, transfer to the reprocessor.