ABSTRACT
Approval of the International Organization for Standardization (ISO) document 10993-7:1995 requires that an evaluation of ethylene oxide (EO) residue limits be performed for two separate sets of requirements: patient exposure as a function of time and absolute values, as in the Food and Drug Administration’s (FDA) 1978 Federal Register monograph. EO remains the predominant mode of product sterilization throughout the medical device industry, both domestically and internationally. The FDA 1978 monograph addresses EO from the perspective of ppm EO based on product classifications, with some consideration for device weight, while ISO takes a completely different approach based on time for short, intermediate, and long-term exposure. The only realistic approach to the dilemma is to evaluate, on a product-by-product basis, what the FDA and ISO requirements are, to utilize the principle of conservatism, and to comply with the more stringent requirement for each situation.
