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This standard establishes requirements, guidance and a risk framework for identification of acceptable approach(es) for assurance of sterility and for selection of alternative SAL(s) or aseptic processing for health care product that cannot be terminally sterilized to achieve an SAL value of 10^-6.

Product Details

Published:

07/29/2019

ISBN(s):

9781570207273

ANSI:

ANSI Approved

Number of Pages:

41

File Size:

1 file , 680 KB