Determination of reprocessing cycle
Article 7
1. Health institutions reprocessing single-use devices shall determine, when applicable together with external reprocessors, the reprocessing cycle for single-use device to be reprocessed. 2. The reprocessing cycle shall be determined based on the documentation and information collected in accordance with Article 5 and the results of a technical assessment including, when appropriate, physical, electrical, chemical, and biological and microbiological tests, and reverse engineering. The reprocessing cycle shall not change the intended purpose of the single-use device, shall take into account the scientific and technical knowledge, and, if applicable, the original method of sterilisation and the relevant standards. 3. The reprocessing cycle shall be established in writing and shall be validated by the health institution reprocessing single-use devices, when applicable, together with external reprocessor. The reprocessing cycle shall describe each step of the reprocessing. For each step, the relevant procedure shall be established and each step shall be validated. Validation of the reprocessing steps shall consist of installation and operational and performance qualification. 4. The validation shall ensure that the performance and safety of the single-use device remains equivalent to the original single-use device after every reprocessing cycle and up to the maximum allowed number of reprocessing cycles. 5. The reprocessing cycle shall be monitored through periodic routine tests and contamination controls, physical, electrical, chemical and biological monitoring and testing of process parameters and calibration. 6. The reprocessed single-use device shall be released after it is confirmed that cleaning, disinfection and sterilization steps and any testing, as appropriate, assure that the reprocessing cycle has been completed in compliance with the requirements applicable to such cycle.