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Ethylene Oxide sterilization is well known in the industry and is accepted as a sterilant by the FDA. It is one of the most popular ways of sterilizing medical devices. It is a great form of sterilization for medical devices that are heat sensitive or sensitive to radiation- such as polymers and plastics that can melt, become brittle or deteriorate. http://bit.ly/fuza5C Nelson Labs provides the EO validation testing. www.nelsonlabs.com.