ABSTRACT
The effects of radiation on packaging and product materials (see Table 7) might not be immediately apparent. Accelerated aging studies expose sterile devices (andlor the packaging) to exaggerated stress or stresses in order to predict the effects of normal stress or stresses on the future functionality and reliability of a product or package (see Appendix 9 for a generic protocol). Using this method results in lower product development costs and earlier product introduction that benefits the patient and the company. Since this is only a predictor of performance, ambient aging should also be performed for a period of time typical of the product's shelf life. Products should be exposed to doses higher than expected for routine sterilization, and nonirradiated controls should be included in the program. A typical program could include devices or material samples exposed at various dose levels between 20-30 and 100 kGy.
