AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices

Association for the Advancement of Medical Instrumentation , 12/13/2010

Publisher: AAMI

File Format: PDF

$129.00$259.00


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

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