Validation of 11 kGy as a radiation sterilization dose for frozen bone allografts.

نویسندگان

  • Huynh Nguyen
  • David A F Morgan
  • Mark R Forwood
چکیده

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 allografts, 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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Radiation Response of Bacteria Associated with Human Cancellous Bone

Cancellous bones from twenty five live tissue donors were tested for bacterial contamination and initial bioburden ranged from 4.1×10 to 3.1×10 cfu/g (average 9.0×10 cfu/g). Forty six representative bacterial isolates were characterized on the basis of morphological, cultural and biochemical characteristics. Staphylococcus spp. was found to be predominant contaminant in tissue samples (41.30%)....

متن کامل

Soft-tissue allografts terminally sterilized with an electron beam are biomechanically equivalent to aseptic, nonsterilized tendons.

BACKGROUND Allograft safety is contingent on effective sterilization. However, current sterilization methods have been associated with decreased biomechanical strength and higher failure rates of soft-tissue allografts. In this study, electron beam (e-beam) sterilization was explored as an alternative sterilization method to preserve biomechanical integrity. We hypothesized that e-beam steriliz...

متن کامل

Effects of ionizing radiation on proteins in lyophilized or frozen demineralized human bone

OBJECTIVE The aim was to study the effects of application of ionizing radiation (gamma and electrons) as sterilizing agents at doses of 15 kGy, 25 kGy and 50 kGy, on lyophilized or frozen demineralized bone tissue for use in transplants. METHODS Five human femoral diaphyses from different donors of musculoskeletal tissue were demineralized and preserved as lyophilized or frozen at -80 °C. The...

متن کامل

Reducing the radiation sterilization dose improves mechanical and biological quality while retaining sterility assurance levels of bone allografts.

BACKGROUND Bone allografts carry a risk of infection, so terminal sterilization by gamma irradiation at 25kGy is recommended; but is deleterious to bone quality. Contemporary bone banking significantly reduces initial allograft bioburden, questioning the need to sterilize at 25kGy. METHODS We inoculated allograft bone with Staphylococcus epidermidis and Bacillus pumilus, then exposed them to ...

متن کامل

The Influence of γ-Ray Irradiation on the Mechanical and Thermal Behaviors of nHA/PA66 Composite Scaffolds

The aim of this study is to investigate the influence of sterilization process using γ -ray radiation on the melting behavior, crystallization behavior, thermal stability, and mechanical properties of nanohydroxyapatite/polyamide66 (nHA/PA66) scaffolds for bone tissue engineering. The results show that the melting temperature, degree of crystallization, thermal stability, and mechanical propert...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • The Journal of arthroplasty

دوره 26 2  شماره 

صفحات  -

تاریخ انتشار 2011