ISO 10993-7 Biological Evaluation of Medical Devices - Test Standard for Ethylene Oxide Sterilization Residues

Medical Device Tests

ISO 10993-7 Biological Evaluation of Medical Devices - Test Standard for Ethylene Oxide Sterilization Residues

ISO 10993-7 specifies the allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO sterilized medical devices, procedures for measuring EO and ECH, and methods for determining compatibility for devices to be released.

ISO 10993-7 Biological Evaluation of Medical Devices - Test Standard for Ethylene Oxide Sterilization Residues

When he developed the "Ethylene Oxide (EtO) sterilization residues", his purpose was twofold: to establish requirements for determining allowable limits for EtO residues in medical devices and to provide analytical methods to demonstrate that an EtO-sterilized device conforms to allowable limits.

EUROLAB assists manufacturers with ISO 10993-7 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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