Validating radiation sterilization.
There are three aspects that manufacturers must address when validating radiation sterilization. These are the minimum dose that ensures sterility, the maximum dose at which radiation affects the functionality of the device, and the dose distribution throughout the product. This article defines a validation protocol that satisfies current radiation sterilization standards.
O'Doherty
J
J
Gammaster Ireland Ltd, Westport, Co. Mayo, Ireland. gil@iol.ie
D004864:Equipment and Supplies; D005060:Europe; D005720:Gamma Rays; D019064:Product Packaging / Q000592:standards*; D011829:Radiation Dosage; D015203:Reproducibility of Results; D013242:Sterilization / Q000379:methods* / Q000592:standards*