EN ISO 11138-2 Standard Test for Sterilization of Health Care Products, Biological Indicators, Ethylene Oxide Sterilization Processes

Medical Tests

EN ISO 11138-2 Standard Test for Sterilization of Health Care Products, Biological Indicators, Ethylene Oxide Sterilization Processes

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 11138-2 standard. This standard specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended for use in the performance evaluation of sterilizers and sterilization processes in which ethylene oxide gas is used as the sterilizing agent, either pure ethylene oxide gas or mixtures of this gas with diluent.

EN ISO 11138-2 Standard Test for Sterilization of Health Care Products, Biological Indicators, Ethylene Oxide Sterilization Processes

The requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.

This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, population and resistance.

It represents the "state of the art" available, according to the specialist manufacturers, users and regulatory authorities involved in the development of this standard. The aim is not to encourage the use of biological indicators for which such use is not recommended, but to provide common requirements for the production of biological indicators known to be used today.

EUROLAB assists manufacturers with EN ISO 11138-2 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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