How to respond to changes in the regulation of the ethylene-oxide sterilisation process.
The standards relating to ethylene-oxide sterilisation of medical devices are being revised. This article examines the implications of the changes for medical device manufacturers and advises what process innovations and other actions can be taken to ensure compliance.
Young
William T
WT
Sterigenics International Inc, Oak Brook, Illinois 60523, USA. byoung@sterigenics.com
D004866:Equipment Contamination / Q000517:prevention & control; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005027:Ethylene Oxide / Q000592:standards*; D006801:Humans; D007221:Industry / Q000592:standards; D007390:International Agencies; D011786:Quality Control; D013242:Sterilization / Q000592:standards*
D005027:Ethylene Oxide