156 TMX428 TMX428CP & TMX58 Service Manual 317-160-406 Rev 4
May 2021
The instructions provided have been validated by the manufacturer of the medical device as being capable
of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the
processing, as actually performed using equipment, materials and personnel in the processing facility,
achieves the desired result. This requires verification and/or validation and routine monitoring of the
process.