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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.
Product Details
- Published:
- 12/13/2010
- ISBN(s):
- 1570204039
- Number of Pages:
- 58
- File Size:
- 1 file , 470 KB