Validation of 11 kGy as a Radiation Sterilisation Dose for Frozen Bone Allografts

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Title Validation of 11 kGy as a Radiation Sterilisation Dose for Frozen Bone Allografts
Author Nguyen, Huynh; Morgan, David A.F.; Forwood, Mark
Journal Name Journal of Arthroplasty
Editor RH Rothman
Year Published 2011
Place of publication United States
Publisher Elsevier
Abstract A radiation sterilization dose (RSD) of 25 kGy is deleterious to bone allografts. This study aimed to establish a lower RSD for bone allografts using method 1 of International Standard Organisation 11137.2:2006. This provides a database to select an RSD corresponding to an allograft's bioburden, given that the bioburden's gamma resistance is equal to or less than the standard. This can be verified by irradiating 100 allografts at a dose selected to provide a sterility assurance level of 10−2. The bioburden of our allografts was 0, which prescribed a verification dose of 1.3 kGy. After irradiating 100 llografts, sterility tests returned no positive cultures. We therefore validated an RSD of 11 kGy for allografts with that bioburden. According to the standard, this RSD provides a sterility assurance level of 10−6 for bone allografts.
Peer Reviewed Yes
Published Yes
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Copyright Statement Copyright 2010 Elsevier Inc. This is the author-manuscript version of this paper. Reproduced in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.
Volume 26
Issue Number 2
Page from 303
Page to 308
ISSN 0883-5403
Date Accessioned 2011-04-27
Language en_US
Research Centre Centre for Musculoskeletal Research; Menzies Health Institute Qld
Faculty Griffith Health Faculty
Subject Orthopaedics
Publication Type Journal Articles (Refereed Article)
Publication Type Code c1

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