Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

1. (1)

   ‘reprocessor’ means the health institution and the external reprocessor reprocessing single-use devices;

2. (2)

   ‘external reprocessor’ means the entity reprocessing single-use devices at the request of a health institution;

3. (3)

   ‘reprocessing cycle’ means a cycle that includes all reprocessing steps applied to a single-use device to ensure that the safety and performance of the reprocessed device is equivalent to that of the original device.