title: VDmax. A new method for substantiating 25 kGy.
abstract: Neither of the standards for the validation and routine control of sterilization of medical devices by ionizing radiation provides detailed guidance on how to substantiate a 25 kGy sterilizing dose. This article describes the basis of a new method for substantiating this dose and how the resulting procedure has been applied in practice.
authors.affiliation: Johnson & Johnson, New Brunswick, New Jersey, USA. jkowals@corus.jnj.com
authors.forename: J B
authors.initials: JB
authors.lastname: Kowalski
authors.forename: A
authors.initials: A
authors.lastname: Tallentire
mesh_terms: D004864:Equipment and Supplies; D005069:Evaluation Studies as Topic; D007221:Industry; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D013242:Sterilization / Q000379:methods*