EN ISO 11138-1 Sterilization of Health Care Products, Biological Indicators, Part 1: Standard Test for General Requirements

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EN ISO 11138-1 Sterilization of Health Care Products, Biological Indicators, Part 1: Standard Test for General Requirements

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 11138-1 standard. EN ISO 11138-1 specifies general requirements for the production, labeling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions and their components, to be used in the validation and routine monitoring of sterilization processes.

EN ISO 11138-1 Sterilization of Health Care Products, Biological Indicators, Part 1: Standard Test for General Requirements

EN ISO 11138-1 specifies the basic and common requirements applicable to all parts of EN ISO 11138. Biological indicator requirements for certain specific processes are provided in the relevant sections of EN ISO 11138. If a specific next part is not provided, this standard applies.

EN ISO 11138-1 does not apply to microbiological test systems for processes based on the physical removal of microorganisms. However, this standard may contain elements related to such microbiological testing systems.

EUROLAB assists manufacturers with EN ISO 11138-1 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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