1. Food and Drug Administration Center for Devices and Radiological Health. US Department of Health and Human Services. FDA proposed strategy on reuse of single-use devices (updated 1 November 1999). Available at http://www.fda.gov/cdrh/comp/guidance/1168.pdf.
2. Food and Drug Administration Center for Devices and Radiological Health, US Department of Health and Human Services. Medical device user fee and modernization act of 2002, validation data in premarket notification submissions (510(k)s) for reprocessed single-use medical devices; guidance for industry and FDA staff (issued 1 June 2004). Available at http://www.fda.gov/cdrh/ode/guidance/1216.pdf.
3. Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten