VDI 5700 Blatt 1:2015-04

The standard provides detailed recommendations for the application of risk management in accordance with DIN EN ISO 14971 in relation to the reprocessing of medical devices, which are optionally also be observed in the development of medical devices. The standard is aimed at personnel entrusted with the duty to produce a product- and process-specific, complete risk analysis during the planning of the reprocessing of a medical device. The standard applies to developers, manufacturers, users and operators of reprocessable medical products as well as devices and systems for the reprocessing processes; for developers, manufacturers and users of process chemicals and media for reprocessing processes; and for developers and users of reprocessing processes, testing facilities and legal authorities. The standard gives a product-neutral and practical overview of the potential risks during reprocessing for patients, users and third parties in the use cycle of a medical device. The standard does not claim to be a complete listing of all aspects to be considered in conjunction with the risk management. Risk control measures are presented.