1. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, Office of Device Evaluation, CDRH, April 1996


  1. Updated 510(k) Sterility Review, Guidance K90-1; Final Guidance for Industry and FDA, Office of Device Evaluation, CDRH, August 30, 2002




See also the WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies, provided with References Relating to Speaker Presentations for Topics 3 & 4,  item #1.