AAMI TIR42:2021

Evaluation of particulate associated with vascular medical devices

Association for the Advancement of Medical Instrumentation , 03/31/2021

Publisher: AAMI

File Format: PDF

$129.00$259.00


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.

AAMI TIR42:2021 History

AAMI TIR42:2021

AAMI TIR42:2021

$129.00 $259.00

AAMI TIR42:2010

AAMI TIR42:2010

$129.00 $259.00

More AAMI Standards PDF

AAMI ST79:2006 and A1:2008 & A2:2009
AAMI BE83:2006/(R)2011

AAMI BE83:2006/(R)2011

$74.00 $149.00

AAMI ES60601-1:2005/(R)2012

AAMI ES60601-1:2005/(R)2012

$566.00 $1,132.00

AAMI ES60601-1:2005

AAMI ES60601-1:2005

$217.00 $435.00