VDmax. A new method for substantiating 25 kGy.
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.
Kowalski
J B
JB
Johnson & Johnson, New Brunswick, New Jersey, USA. jkowals@corus.jnj.com
Tallentire
A
A
D004864:Equipment and Supplies; D005069:Evaluation Studies as Topic; D007221:Industry; D011829:Radiation Dosage; D011839:Radiation, Ionizing; D013242:Sterilization / Q000379:methods*