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This American National Standard specifies a procedure by which a manufacturer can identify thehazards associated with medical devices and their accessories (including in vitro diagnosticmedical devices), estimate and evaluate the risks, control these risks, and monitor theeffectiveness of the control.

Product Details

Published:

10/16/2000

ANSI:

ANSI Approved

Number of Pages:

41

File Size:

1 file , 190 KB