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

AAMI-TIR12 - 2020 EDITION - CURRENT
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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

Revision Level

2020 EDITION

Status

Current

Publication Date

Dec. 21, 2020

Page Count

73 pages