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
