This document addresses vascular exposure to particles arising from the manufacturing
environment for medical devices and from the use of medical devices. This TIR is intended to offer
guidance to medical device manufacturers in applying analytical methods for particulate testing,
identifying potential sources of particulates, and developing limits for particulates.
Document identifier
AAMI TIR42:2010
Title
Evaluation of particulates associated with vascular medical devices
AAMI Category
Implants and Artificial Organs, Other than Dialysis
Publication date
2010-12-13
International Relationship
| Price |
228 vnd |
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