title: Implementing standards for radiation sterilization. The challenges.
abstract: 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.
authors.affiliation: Medical Devices Agency, London, UK.
authors.forename: E
authors.initials: E
authors.lastname: Hoxey
authors.forename: N
authors.initials: N
authors.lastname: Thomas
authors.forename: A
authors.initials: A
authors.lastname: Tallentire
mesh_terms: D004864:Equipment and Supplies; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D013242:Sterilization / Q000379:methods / Q000592:standards*