Article 8 Maximum number of reprocessing cycles

Each reprocessing in accordance with Article 11 shall be counted as one reprocessing cycle. Each reprocessing cycle of a single-use device shall be counted to determine the maximum number of reprocessing cycles even if a single-use device was not reused on a patient following the reprocessing.

The health institution, together with the external reprocessor, when applicable, shall determine the maximum number of reprocessing cycles which can be applied to the reprocessed single-use device, during which the performance and safety of that single-use device remains equivalent to the original single-use device.

Once the maximum number of reprocessing cycles has been reached, the reprocessed single-use device shall be disposed of.