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If you're wondering what EO stands for, read on! EO Testing is an acronym for ethylene oxide, and it's used to denote the process of sterilizing a product. In sterilization, this substance is released into the environment after sterilization. Some sterilization products contain EO residuals. EO levels are listed in ISO 10993-7. When determining whether a product contains EO residues, consider the following considerations:
While ethylene oxide is a commonly used chemical for sterilization, its emission levels can cause health problems. Some research has linked EtO to cancer. While the U.S. Environmental Protection Agency has not yet banned the use of ethylene oxide, it has proposed banning it in all sterilization facilities. The agency's proposal would require sterilizing facilities to adopt alternative sterilization processes, which may lead to public health issues.
Another concern is that EO can cause a decrease in the effectiveness of sterile products. The EPA has repeatedly recommended that manufacturers reduce their EtO emissions to meet global standards. The failure of the EPA to act on this issue could negatively affect U.S. medical equipment and cause other health concerns. In addition to reducing EtO emissions, the agency is holding a challenge to find alternatives to the chemical.
In addition to the requirement for BI, EO sterilization is also required to demonstrate the appropriateness of biological indicators. ISO 11135:2014 specifies a process for testing bioburden and BIs. For example, if an EO sterilization process is used in a production setting, a BI must be tested before it is put into the final production process. The results of this test will be compared to the BI results.
The process used to sterilize medical devices with EtO gas is the most common form of sterilization. It is a low-temperature gas and compatible with many materials. Among the many medical devices EtO sterilizes are: heart valves, pacemakers, surgical kits, gowns, drapes, and more. The chemical also has a variety of uses in everyday life and can be found in fabrics, textiles, and personal care items.
While ethylene oxide is a commonly used chemical for sterilization, its emission levels can cause health problems. Some research has linked EtO to cancer. While the U.S. Environmental Protection Agency has not yet banned the use of ethylene oxide, it has proposed banning it in all sterilization facilities. The agency's proposal would require sterilizing facilities to adopt alternative sterilization processes, which may lead to public health issues.
Another concern is that EO can cause a decrease in the effectiveness of sterile products. The EPA has repeatedly recommended that manufacturers reduce their EtO emissions to meet global standards. The failure of the EPA to act on this issue could negatively affect U.S. medical equipment and cause other health concerns. In addition to reducing EtO emissions, the agency is holding a challenge to find alternatives to the chemical.
In addition to the requirement for BI, EO sterilization is also required to demonstrate the appropriateness of biological indicators. ISO 11135:2014 specifies a process for testing bioburden and BIs. For example, if an EO sterilization process is used in a production setting, a BI must be tested before it is put into the final production process. The results of this test will be compared to the BI results.
The process used to sterilize medical devices with EtO gas is the most common form of sterilization. It is a low-temperature gas and compatible with many materials. Among the many medical devices EtO sterilizes are: heart valves, pacemakers, surgical kits, gowns, drapes, and more. The chemical also has a variety of uses in everyday life and can be found in fabrics, textiles, and personal care items.
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