Implementing standards for radiation sterilization. The challenges.
This article discusses the limitations of the methods offered in the radiation standards for selecting radiation dose. It highlights the difficulty of using these methods for product-specific dose-setting and, in particular, their inability to determine this for products with low bioburdens. Issues relating to the appropriateness of 25 kGy are also discussed.
Hoxey
E
E
Medical Devices Agency, London, UK.
Thomas
N
N
Tallentire
A
A
D004864:Equipment and Supplies; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D013242:Sterilization / Q000379:methods / Q000592:standards*