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About This Item


Full Description

This document addresses vascular exposure to particles arising from the manufacturing environment for medical devices and from the use of medical devices. This TIR is intended to offer guidance to medical device manufacturers in applying analytical methods for particulate testing, identifying potential sources of particulates, and developing limits for particulates.

Document History

  1. AAMI TIR42:2021

    Evaluation of particulate associated with vascular medical devices

    • Most Recent
  2. AAMI TIR42:2010


    Evaluation of particulates associated with vascular medical devices

    • Historical Version