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AAMI TIR42:2021

Evaluation of particulates associated with vascular medical devices
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AAMI TIR42:2021

Evaluation of particulates associated with vascular medical devices

AAMI TIR42:2021
This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. This TIR is intended to offer guidance to the medical device industry when evaluating the tendency for medical devices to release particulate, identifying particulate sources, applying analytical methods for particulate testing, and developing particulate limits based on clinical risk.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number
Publication Date Not Available
Language en - English
Page Count 47
Revision Level
Supercedes
Committee
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