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Full Description

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.
 

Document History

  1. AAMI TIR42:2021

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    Evaluation of particulate associated with vascular medical devices

    • Most Recent
  2. AAMI TIR42:2010


    Evaluation of particulates associated with vascular medical devices

    • Historical Version