AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices

Association for the Advancement of Medical Instrumentation , 12/13/2010

Publisher: AAMI

File Format: PDF

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Description

Standard By:Association for the Advancement of Medical Instrumentation , 12/13/2010

Published:12/13/2010

Pages:58

ISBN(s):1570204039

File Size:1 file , 470 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

This document addresses vascular exposure to particles arising from the manufacturingenvironment for medical devices and from the use of medical devices. This TIR is intended to offerguidance to medical device manufacturers in applying analytical methods for particulate testing,identifying potential sources of particulates, and developing limits for particulates.