AAMI-TIR12 Historical Revision Information
Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

AAMI-TIR12 - 1994 EDITION - SUPERSEDED
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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

Revision Level

1994 EDITION

Status

Superseded

Publication Date

Nov. 24, 1994