Sterile medical device packaging testing methods

Most medical devices require sterilization before packaging and use. The most common methods for doing this include -irradiation, exposure to ethylene oxide (EtO) gas or electron beam (E-beam). Contact with radiation, ethylene oxide or electron beam can affect not only the microorganisms of concern, but also potentially the medical device or package. The physical properties were tested after irradiation to define any deleterious effect... 

EN 868-1 1997, Packaging materials and systems for medical devices which are to be sterilized—Part 1 General requirements and test methods. February 1997. 

Jones, Lois, et al., In Quest of Sterile Packaging Part 2, Physical Package Integrity Test Methods, Medical Device and Diagnostics Industry, September 1995. 

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