VDI 5700 Blatt 2:2017-06

This standard provides the frame conditions for a technical training according to standard VDI 5700 Part 1 for personnel entrusted with the risk management of reprocessing medical devices. The respective education frame covers a further training of staff in the field of reprocessing medical devices (process relevant education) as well as a further training of staff of medical product manufacturers and particularly developers (product relevant training). The standard serves for quality assurance at the execution of the risk management process by making demands to experts being in charge of the training, describing training contents, providing framework conditions for the training expiry, stipulating test conditions for the final examination. Based on this standard, contents to be observed at the execution of the risk management process in conjunction with the reprocessing of medical products shall be conveyed. Among others, the training covers detailed recommendations on the basis of VDI 5700 Part 1 for the application of the risk management according to DIN EN ISO 14971 with respect to the reprocessing of medical products which are optionally to be considered at the development of medical products. The trainings provide a product neutral and practise-oriented summary of possible risks during reprocessing in the use cycle of a medical device considering patients, users and third parties. Risk control measures are represented.