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AAMI TIR42:2010
Evaluation of particulates associated with vascular medical devicesMore info
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 application of analytical methods for particulate testing, identifying potential sources of particulates, and developing limits for particulates.
| Author | AAMI |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| ICS | 11 : Health care technology |
| Number of pages | 58 |
| Year | 2010 |
| Country | USA |