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AAMI TIR42:2021

Evaluation of particulate associated with vascular medical devices

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.

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Association for the Advancement of Medical Instrumentation [AAMI]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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