Historical
AAMI TIR12:2010 RED LINE
(Red Line Version) Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annex. Redline version notes changes from 2004 edition.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
