AAMI-TIR12 › Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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This document is also known as: AAMI TIR12:2010, AAMI TIR12
Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
Abstract
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, 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, as are a bibliography and other informative annexes.
Keywords
cleaning, decontamination, disinfection, medical device design, sterilization
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Document Number
AAMI TIR12:2020/(R)2023
Revision Level
2020 R23 EDITION
Status
Current
Publication Date
Jan. 1, 2023