Article 20 Labelling and provision of instructions for use

Reprocessed single-use devices shall bear the word ‘reprocessed’ on their label, as well as the status of the single-use device: ‘disinfected’ or ‘sterilized’, followed by the sterilization method or disinfection method, and shelf life.

The name and address of the health institution, and the external reprocessor if applicable, shall be clearly indicated on the label and in the instructions for use of the single-use device.

The maximum number of reprocessing cycles allowed and the number of reprocessing cycles performed shall clearly appear on the label.