AAMI TIR42

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Evaluation of particulate associated with vascular medical devices

Published by Publication Date Number of Pages
AAMI 03/31/2021 47
Category:

Description

AAMI TIR42 – 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.

Product Details

Published:
03/31/2021
ISBN(s):
9781570207877
Number of Pages:
47
File Size:
1 file , 630 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus

Documents History