ABSTRACT
This chapter discusses the newest requirements along with suggestions on obtaining reliable data. Since 1978, medical device manufacturers have used ethylene oxide (EO) residue guidelines with published limits but no direction on sampling or analysis. International Organization for Standardization (ISO) 10993-7 has established limits for EO residues using health-based risk assessment. A Food and Drug Administration 1978 proposed guideline set limits based on a device’s intended use, while the ISO categorization is based on contact time. The ISO guideline states that certain steps must be taken to “minimize or control the effects of laboratory conditions on the rate of aeration for test samples that have been removed from a product load.” With the significant changes outlined in the ISO guideline on EO residues, manufacturers must be aware of proper sample handling and analysis in order to ensure that the data are reliable and representative of actual conditions.
