AAMI TIR42:2021 PDF Download
Standard EN Sample
Evaluation of particulate associated with vascular medical devices
Also Known As:
SKU171154833
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2021-03-31
Pages CountPages47
Full Description
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.
Details
| Language(s) | English |
| ISBN | 9781570207877 |
| File Size | 1.3 MB |
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